Data / Medical devices / United States / Varian Medical Systems, Inc
Varian Medical Systems, Inc: FDA-registered device maker in Palo Alto, CA, United States, 37 510(k) clearances
Varian Medical Systems, Inc is registered with the FDA (registration 2916710) in Palo Alto, CA, United States. It lists 5 device types. The FDA files 37 510(k) clearances under its listings, the newest dated January 21, 2026. 123 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2916710
- Address
- 911 Hansen Way, Palo Alto, CA, United States, 94304
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 26, 2000
- Registered through
- 2027
- Brand names listed
- 4D Integrated Treatment Console v13 MR4, 4D Treatment Console V.13, Acuity with Conebeam Computed Tomography, Anchored Beacon Transponder, Beacon Care Package - Soft Tissue (17G), Calypso Permanent Beacon Transponders, Calypso Prostate Beacon Transponders, Calypso Soft Tissue Beacon Transponders and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 2 | Manufacturer | accessdata.fda.gov |
| System, Simulation, Radiation Therapy | KPQ | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 21, 2026 | K252977 | Halcyon, Ethos Radiotherapy System (5.0) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 7, 2025 | K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 16, 2025 | K250099 | Mobius3D (4.1) | IYE | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| December 21, 2023 | K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| November 3, 2023 | K232113 | Halcyon, Ethos Radiotherapy System | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| September 12, 2023 | K231317 | TrueBeam, TrueBeam STx, Edge, VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 22, 2023 | K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 17, 2023 | K222941 | Halcyon, Ethos Radiotherapy System | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| June 3, 2022 | K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 12, 2021 | K203766 | 4D Integrated Treatment Console | MUJ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 14, 2021 | K203669 | Mobius3D | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 10, 2020 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| June 28, 2018 | K181404 | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 6, 2018 | K170570 | Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 2, 2018 | K180586 | Varian Head Frame | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| July 28, 2017 | K172013 | VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| July 12, 2017 | K171733 | TrueBeam, TrueBeam STx, Edge | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 19, 2017 | K162472 | TrueBeam-TrueBeam STx-Edge | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 12, 2016 | K162476 | Varian High Energy Linear Accelerator | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| November 25, 2015 | K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 26, 2015 | K151882 | Varian Treatment (VTx) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 8, 2015 | K150706 | VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 19, 2014 | K143224 | TrueBeam-TrueBeam STx-Edge | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 11, 2014 | K142560 | Varian Head Frame | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 2, 2014 | K142268 | Varian Verification System (VVS) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 27, 2014 | K141230 | DOSELAB PRO | IYE | Substantially Equivalent | Mobius Medical Systems, LP | accessdata.fda.gov |
| January 31, 2014 | K133240 | VARIAN MULTILEAF COLLIMATOR | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 27, 2014 | K133331 | 4D INTEGRATED TREATMENT CONSOLE | MUJ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 11, 2013 | K131807 | HIGH ENERGY LINEAR ACCELERATOR | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 21, 2013 | K124002 | VERIFICATION CONSOLE | LHN | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| January 15, 2013 | K123788 | INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 5, 2012 | K123137 | CALYPSO SYSTEM | IYE | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| February 16, 2012 | K112841 | SURFACE BEACON TRANSPONDERS | IYE | Substantially Equivalent | Calypso Medical Technologies, Inc. | accessdata.fda.gov |
| October 15, 2010 | K102024 | RPM RESPIRATORY GATING SYSTEM | IYE | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| August 15, 2007 | K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) | IYE | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| December 30, 2003 | K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | KPQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 23, 2003 | K033343 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 123.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 12, 2019 | 85269 | Class II | Terminated | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is inte | After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only wit | accessdata.fda.gov |
| December 26, 2018 | 81912 | Class II | Terminated | Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant o | There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the | accessdata.fda.gov |
| December 2, 2016 | 76018 | Class II | Terminated | Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiothera | Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled. | accessdata.fda.gov |
| September 13, 2016 | 75296 | Class II | Terminated | Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and | Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue | accessdata.fda.gov |
| June 23, 2016 | 74585 | Class II | Terminated | Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed tr | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS]. | accessdata.fda.gov |
| January 11, 2016 | 73092 | Class II | Terminated | Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignan | When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure. | accessdata.fda.gov |
| September 28, 2015 | 72374 | Class II | Terminated | ARIA Radiation Oncology, versions 10, 11, 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application. | An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx. | accessdata.fda.gov |
| August 18, 2014 | 69126 | Class II | Terminated | 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commenci | Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV. | accessdata.fda.gov |
| June 17, 2014 | 68627 | Class II | Terminated | C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate o | Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode. | accessdata.fda.gov |
| April 30, 2014 | 69637 | Class II | Terminated | Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical | Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc tion assembly cable and the ground stud on the lid of the High Voltage Module. | accessdata.fda.gov |
| March 20, 2014 | 67896 | Class II | Terminated | On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to i | Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning. | accessdata.fda.gov |
| November 18, 2013 | 66956 | Class II | Terminated | Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in r | An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change. | accessdata.fda.gov |
| October 24, 2013 | 66764 | Class II | Terminated | C-Series: Clinac, Trilogy, Trilogy Tx., Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Li | This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation. | accessdata.fda.gov |
| March 26, 2013 | 64828 | Class II | Terminated | Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their | Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. | accessdata.fda.gov |
| January 28, 2013 | 64319 | Class II | Terminated | Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. | The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used. | accessdata.fda.gov |
| November 5, 2012 | 63713 | Class II | Terminated | Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Refe | Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import. | accessdata.fda.gov |
| September 24, 2012 | 63471 | Class II | Terminated | ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. | An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued. | accessdata.fda.gov |
| August 17, 2012 | 63093 | Class II | Terminated | Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclip | Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose. | accessdata.fda.gov |
| August 14, 2012 | 63033 | Class II | Terminated | Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, | Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-d | accessdata.fda.gov |
| July 2, 2012 | 62562 | Class II | Terminated | Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Pal | A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported. | accessdata.fda.gov |
| June 18, 2012 | 62420 | Class II | Terminated | Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Ecli | Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Uni | accessdata.fda.gov |
| April 9, 2012 | 61694 | Not yet classified | Terminated | TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is i | Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of. | accessdata.fda.gov |
| April 9, 2012 | 61693 | Not yet classified | Terminated | True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Varian Medical Systems, Palo Alto, CA. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision ra | A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam. | accessdata.fda.gov |
| January 30, 2012 | 61198 | Not yet classified | Terminated | Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Palo Alto, CA. Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radio | Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. | accessdata.fda.gov |
| January 30, 2012 | 61196 | Not yet classified | Terminated | TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision ra | An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning. | accessdata.fda.gov |
| January 30, 2012 | 61193 | Not yet classified | Terminated | FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA. Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics compute | An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to "Discard" that slice, an incorrect calculation of the isocenter location may result. | accessdata.fda.gov |
| January 16, 2012 | 61074 | Not yet classified | Terminated | Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model Number(s): All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Sys | When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose. | accessdata.fda.gov |
| December 16, 2011 | 60830 | Not yet classified | Terminated | Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product | Varian received customer complaints involving ARIA Oncology Information Systems, where the Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation. | accessdata.fda.gov |
| December 12, 2011 | 60837 | Not yet classified | Terminated | Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alt | An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and then used as the beam limiting device for the dose calculation. This will result in an incorrect dose distribution within Eclipse. | accessdata.fda.gov |
| December 12, 2011 | 60829 | Not yet classified | Terminated | 4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator Varian Medical Systems, Palo Alto, CA. The 4DITC is designed to interface to the Varian Clinac Treatment Control System for the purpose of providing ver | Varian has discovered that on 4D Integrated Treatment Console and TrueBeam, the ad-hoc CIAO(Complete Irradiated Area Outline) calculation results in the CIAO generation that is different from the CIAO in RT Chart. The 4DITC algorithm adds dose for the control point at field edge, which should not be added according to the system specifications. | accessdata.fda.gov |
| December 12, 2011 | 60826 | Not yet classified | Terminated | Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873, Model Number: H51, distributed by and manufactured by: Varian Medical Systems Inc., Palo Alto, CA The 4D Integrated Treat | When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being updated correctly. | accessdata.fda.gov |
| November 28, 2011 | 60659 | Not yet classified | Terminated | Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Product is manufactured and distributed by Varian M | An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. | accessdata.fda.gov |
| November 23, 2011 | 60684 | Not yet classified | Terminated | Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical lan | An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images. | accessdata.fda.gov |
| November 10, 2011 | 61012 | Not yet classified | Terminated | Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Syst | Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted. | accessdata.fda.gov |
| October 31, 2011 | 60441 | Not yet classified | Terminated | Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart module), Reference/FSCA Identifier: CP-05 | An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse. | accessdata.fda.gov |
| October 31, 2011 | 60411 | Not yet classified | Terminated | TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radi | An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape. | accessdata.fda.gov |
| October 6, 2011 | 60231 | Not yet classified | Terminated | Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactu | The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector. | accessdata.fda.gov |
| October 4, 2011 | 60238 | Not yet classified | Terminated | Head Ring Posts with part number - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floorstand devices. Varian Medical Systems, Palo Alto, CA 94304. The Optical Guidance Platform is fo | An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage. | accessdata.fda.gov |
| September 9, 2011 | 60022 | Not yet classified | Terminated | Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. Manufactured by Varian Medical System, Palo Alto, CA. Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision rad | Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode. | accessdata.fda.gov |
| July 21, 2011 | 59586 | Not yet classified | Terminated | 4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3; Varian Medical Systems, Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing the radiation therapy de | The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system. | accessdata.fda.gov |
| July 20, 2011 | 59572 | Not yet classified | Terminated | Varian Treatment version 6.6.5052. Varian Medical Systems, Palo Alto, Ca Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation | Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field. | accessdata.fda.gov |
| July 13, 2011 | 59404 | Not yet classified | Terminated | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical | Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | accessdata.fda.gov |
| July 13, 2011 | 59402 | Not yet classified | Terminated | Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum. | Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error. | accessdata.fda.gov |
| July 13, 2011 | 59401 | Not yet classified | Terminated | GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany Product Usage: Th | Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. | accessdata.fda.gov |
| July 13, 2011 | 59388 | Not yet classified | Terminated | GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. Varian Medical Systems, Palo Alto, CA. Mfg by Varian Medical Systems, Haan GmbH. Flexible Applicator Robes are designed for brachytherapy intracavitary tre | Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave. | accessdata.fda.gov |
| July 7, 2011 | 59394 | Not yet classified | Terminated | Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48; Reference/FSCA Identifier: CP-04931; Product is manu | An anomaly has been identified in the 4D Structure Merge option of certain versions of Varian's Eclipse Treatment Planning System. The treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the MU or calculated dose distribution. | accessdata.fda.gov |
| June 30, 2011 | 59378 | Not yet classified | Terminated | Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases. It is used | In affected Eclipse versions, the treatment field energy may change from the current selection to a previous selection without use intervention and without invalidating the MU or calculated dose distribution. | accessdata.fda.gov |
| June 27, 2011 | 59351 | Not yet classified | Terminated | Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems | In certain configurations, the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal Arc, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being diff | accessdata.fda.gov |
| June 23, 2011 | 59350 | Not yet classified | Terminated | Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51; Reference/PSCA Identifier: CP-03940; Product is manufactured and distributed by Varian Medical Syste | Varian has scheduled for an upgrade of the device from current version to 10.2. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history information. | accessdata.fda.gov |
| June 21, 2011 | 59262 | Not yet classified | Terminated | On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The On-Board Imager device is used for ve | Varian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s. | accessdata.fda.gov |
| June 6, 2011 | 59226 | Not yet classified | Terminated | High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape | When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose. | accessdata.fda.gov |
| May 31, 2011 | 64997 | Class II | Terminated | Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and p | Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or sl | accessdata.fda.gov |
| May 26, 2011 | 59087 | Not yet classified | Terminated | Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the bo | On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions. | accessdata.fda.gov |
| May 24, 2011 | 59088 | Not yet classified | Terminated | Clinac Linear Accelerators; Varian Medical Systems, Palo Alto, CA. Radiation Therapy intended to deliver megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. | The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient. | accessdata.fda.gov |
| May 20, 2011 | 59006 | Not yet classified | Terminated | Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Radiotherapy treatment for patients with malignant and benign diseases. | A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results. | accessdata.fda.gov |
| May 19, 2011 | 58994 | Not yet classified | Terminated | TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in | Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry. | accessdata.fda.gov |
| May 18, 2011 | 58976 | Not yet classified | Terminated | Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions any | The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing. | accessdata.fda.gov |
| May 17, 2011 | 58974 | Not yet classified | Terminated | ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, | An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the "Convert to Setup Field" option, a Set-up field is created, that removes the DMLC plan components in order to create an open collimator field for setup purposes. | accessdata.fda.gov |
| May 13, 2011 | 58970 | Not yet classified | Terminated | Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when | Some drive stand bolts may fail to meet mechanical specifications. | accessdata.fda.gov |
| May 13, 2011 | 58969 | Not yet classified | Terminated | Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) Varian Medical Systems, Inc. Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradi | In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions. | accessdata.fda.gov |
| May 3, 2011 | 58836 | Not yet classified | Terminated | Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc.. | In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up to 10%. | accessdata.fda.gov |
| April 5, 2011 | 58590 | Not yet classified | Terminated | Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19 | Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities are not available on one of the two cameras. The image has abnormally abrupt transitions from dark to light portions, witho | accessdata.fda.gov |
| April 4, 2011 | 58581 | Not yet classified | Terminated | Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System | An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval. | accessdata.fda.gov |
| March 31, 2011 | 58558 | Not yet classified | Terminated | Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Indicated for stereotactic radiosurger | The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing. | accessdata.fda.gov |
| March 30, 2011 | 58505 | Not yet classified | Terminated | Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Systems Inc., Palo Alto, CA. For use with a charged particle accelerator to perform precise positioning | A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error. | accessdata.fda.gov |
| March 28, 2011 | 58438 | Not yet classified | Terminated | Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy | Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail. | accessdata.fda.gov |
| March 17, 2011 | 58474 | Not yet classified | Terminated | Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the | An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel. | accessdata.fda.gov |
| March 9, 2011 | 58424 | Not yet classified | Terminated | ARIA, RT Chart Application v 8.0 through 8.9 Varian Medical Systems, Palo Alto, CA. Aria Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, m | An issue was identified with the gantry rotation direction when creating opposing field within the RT Chart function of ARIA, or possibly with third party planning systems and delivering the plan at 4DITC. | accessdata.fda.gov |
| March 3, 2011 | 58252 | Not yet classified | Terminated | Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is | The anomaly that has been identified with the Optical Guidance Platform (OGP) software may not be always displaying the correct transfer date on the patient file. | accessdata.fda.gov |
| March 3, 2011 | 58246 | Not yet classified | Terminated | Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03899; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a cha | The optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations. | accessdata.fda.gov |
| February 28, 2011 | 58230 | Not yet classified | Terminated | The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The 4D | A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery. | accessdata.fda.gov |
| February 24, 2011 | 58240 | Not yet classified | Terminated | Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14, H18, H27, H29, HCX; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy | The wedge angle labeling on the wedge tray may not correctly match the wedge body. However, the wedge body is labeled with the correct wedge angle. | accessdata.fda.gov |
| February 18, 2011 | 58112 | Not yet classified | Terminated | ARIA versions 8.0 and 8.1 Varian Medical Systems, Palo Alto, CA 94304 The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, sto | An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect. | accessdata.fda.gov |
| February 7, 2011 | 58072 | Not yet classified | Terminated | Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy. | An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation. | accessdata.fda.gov |
| December 14, 2010 | 57527 | Not yet classified | Terminated | 4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Varian Medial Systems, Palo Alto, CA Designed to assist the operator of a radiation device in providing accurate treatment set-ups for each | Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that mulitplex isocenter is present. | accessdata.fda.gov |
| December 10, 2010 | 57610 | Not yet classified | Terminated | Varian High Energy Linear Accelerator: Varian Medical Systems, Palo Alto, CA 94304 Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation | An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification. | accessdata.fda.gov |
| July 20, 2010 | 56774 | Not yet classified | Terminated | Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA | The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option | accessdata.fda.gov |
| June 23, 2010 | 56182 | Not yet classified | Terminated | Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX | Position errors may result in misdelivery of radiation. | accessdata.fda.gov |
| June 10, 2010 | 56347 | Not yet classified | Terminated | Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Ra | The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch. | accessdata.fda.gov |
| May 24, 2010 | 56346 | Not yet classified | Terminated | Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA | Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "Apply Shift" and presses Motion Enable buttons. This can result in the actual patient position differing from that position indicated by the imaging application affecting poistion accuracy and precision. | accessdata.fda.gov |
| May 13, 2010 | 56012 | Not yet classified | Terminated | Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x; Model Numbers: H48/H83. | Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneously can result in a corrupted (but accessible) treatment plan record. | accessdata.fda.gov |
| April 19, 2010 | 56349 | Not yet classified | Terminated | Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA | The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails. | accessdata.fda.gov |
| March 23, 2010 | 56024 | Not yet classified | Terminated | Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA Treatment Planning System is intended as aid in quickly and precisely planning the | Due to software Issue, an error occurs when performing cone planning using MRI, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue. | accessdata.fda.gov |
| January 19, 2010 | 56350 | Not yet classified | Terminated | Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulat | There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly. | accessdata.fda.gov |
| December 9, 2009 | 54648 | Not yet classified | Terminated | Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x). For radiation therapy. | Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan. | accessdata.fda.gov |
| December 1, 2009 | 56354 | Not yet classified | Terminated | Varian brand C Series Clinics (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/or Manufactured by: Varian Medical Systems Inc., Palo Alto, CA The system consists of two major comp | A circuit design anomaly whereby a faulty balance potentiometer can lead to an undetected electron beam asymmetry. | accessdata.fda.gov |
| October 16, 2009 | 54146 | Not yet classified | Terminated | 4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc | Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field. | accessdata.fda.gov |
| October 8, 2009 | 53778 | Not yet classified | Terminated | C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerator intended to deliver | Product may deliver radiation treatment to areas larger than intended,to healthy tissue. | accessdata.fda.gov |
| September 15, 2009 | 53461 | Not yet classified | Terminated | VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Varian Medical Systems, Palo Alto, CA. | Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed. | accessdata.fda.gov |
| July 17, 2009 | 53045 | Not yet classified | Terminated | Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. | Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered. | accessdata.fda.gov |
| May 29, 2009 | 52636 | Not yet classified | Terminated | Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto, CA. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conven | Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly. | accessdata.fda.gov |
| May 8, 2009 | 52654 | Not yet classified | Terminated | Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA The Varis RV function is designed to assist the operator of a radia | Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly. | accessdata.fda.gov |
| January 26, 2009 | 51217 | Not yet classified | Terminated | Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the Clinac 600C). | Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact. | accessdata.fda.gov |
| November 21, 2008 | 50496 | Not yet classified | Terminated | Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. | Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded. | accessdata.fda.gov |
| October 2, 2008 | 50143 | Not yet classified | Terminated | Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms | When using the multiple static segment option, the device may alter dose delivery. | accessdata.fda.gov |
| August 11, 2008 | 49399 | Not yet classified | Terminated | Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered radiation therapy patient support assembly is an electrically | During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers. | accessdata.fda.gov |
| June 11, 2008 | 48730 | Not yet classified | Terminated | Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments. | Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters. | accessdata.fda.gov |
| June 2, 2008 | 48661 | Not yet classified | Terminated | Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Designed to assist the ope | A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect. | accessdata.fda.gov |
| May 29, 2008 | 48654 | Not yet classified | Terminated | Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA The product is a radiation treatment planning system. | Due to issues with image orientation verification, a patient may receive all or some of prescribed high dose to healthy tissue instead of intended area. | accessdata.fda.gov |
| May 21, 2008 | 48652 | Not yet classified | Terminated | Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring paramet | Dose delivery may be altered after import from a third party planning system during radiation therapy. | accessdata.fda.gov |
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Updated January 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.