Data / Medical devices / Germany / Brainlab Se
Brainlab Se: FDA-registered device maker in Munich Bavaria, Germany, 75 510(k) clearances
Brainlab Se is registered with the FDA (registration 8043933) in Munich Bavaria, Germany. It lists 38 device types. The FDA files 75 510(k) clearances under its listings, the newest dated October 5, 2026. 40 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8043933
- FEI number
- 3002619595
- Address
- Olof-Palme-Strasse 9, Munich Bavaria, Germany, 81829
- Owner or operator
- Brainlab SE (9004547)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 23, 2007
- Registered through
- 2027
- Brand names listed
- (Elements) Cranial SRS w/ Cones, (Elements) Cranial SRS; (Elements) Spine SRS, (Elements) Dose Review, (Elements) Multiple Brain Mets SRS, (Elements) RT Planning Platform, (Elements) Retreatment Review, 27 Display Drape, 27 Touchdisplay Foreseeson and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 5, 2026 | K261655 | RT Elements (4.6) | MUJ | Substantially Equivalent | Brainlab SE | accessdata.fda.gov |
| September 30, 2026 | K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | OLO | Substantially Equivalent | Brainlab SE | accessdata.fda.gov |
| January 14, 2026 | K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | IYE | Substantially Equivalent | Brainlab SE | accessdata.fda.gov |
| October 16, 2025 | K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | LLZ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| September 12, 2025 | K252562 | Spine & Trauma Navigation Instruments | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| July 22, 2025 | K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | OWB | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| June 23, 2025 | K243142 | Cranial 4Pi Immobilization | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| June 17, 2025 | K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | MUJ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| June 13, 2025 | K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | QIH | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 16, 2025 | K242569 | Mixed Reality Spine Navigation | SBF | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| March 28, 2025 | K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | OWB | Substantially Equivalent | Medphoton GmbH | accessdata.fda.gov |
| January 28, 2025 | K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| July 24, 2024 | K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 23, 2024 | K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 21, 2024 | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | LLZ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 22, 2024 | K234068 | ART-Plan (v.2.2.0) | MUJ | Substantially Equivalent | Therapanacea Sas | accessdata.fda.gov |
| March 20, 2024 | K234047 | Automatic Registration | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| December 22, 2023 | K232479 | ART-Plan | MUJ | Substantially Equivalent | Therapanacea | accessdata.fda.gov |
| November 20, 2023 | K231498 | TraumaCad Neo | LLZ | Substantially Equivalent | Brainlab , Ltd. | accessdata.fda.gov |
| September 9, 2023 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| August 2, 2023 | K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| July 21, 2023 | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| July 14, 2023 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | QIH | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 11, 2023 | K231052 | ExacTrac Dynamic 1.1.2 | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 27, 2023 | K223734 | ENT EM | PGW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 19, 2023 | K230023 | ART-Plan | QKB | Substantially Equivalent | Therapanacea Sas | accessdata.fda.gov |
| April 19, 2023 | K223552 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| March 14, 2023 | K223279 | RT Elements (4.0) | MUJ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| February 22, 2023 | K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | HAW | Substantially Equivalent | PAJUNK GmbH Medizintechnologie | accessdata.fda.gov |
| October 27, 2022 | K222966 | Cirq Arm System (2.0);Alignment System Spine | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| September 8, 2022 | K213989 | Cranial EM System | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| August 30, 2022 | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 29, 2022 | K220338 | ExacTrac Dynamic | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 19, 2022 | K213930 | Brainlab Elements Guide XT, Guide 3.0 | QQC | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 13, 2022 | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| December 16, 2021 | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio | LLZ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| November 12, 2021 | K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| November 3, 2021 | K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| July 22, 2021 | K211939 | ExacTrac Dynamic | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 9, 2021 | K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review | MUJ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| March 18, 2021 | K203679 | Automatic Registration | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| January 29, 2021 | K201752 | Disposable Pre-calibrated Suction | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| December 23, 2020 | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| December 22, 2020 | K203281 | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X | OWB | Substantially Equivalent | Medphoton GmbH | accessdata.fda.gov |
| November 12, 2020 | K203173 | ExacTrac Dynamic | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| October 8, 2020 | K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| August 19, 2020 | K202050 | Cranial 4Pi Immobilization | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| January 23, 2020 | K191014 | Elements Viewer | LLZ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| September 6, 2019 | K190250 | Microscope Navigation | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| August 29, 2019 | K183605 | Spine & Trauma Navigation | OLO | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| August 1, 2019 | K190887 | Leksell Vantage Stereotactic System | HAW | Substantially Equivalent | Elekta Instrument AB | accessdata.fda.gov |
| April 25, 2019 | K190042 | Brainlab Elements Image Fusion Angio | LLZ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| March 15, 2018 | K180393 | AIRO Computed Tomography (CT) X-ray System | JAK | Substantially Equivalent | Mobius Imaging, LLC | accessdata.fda.gov |
| February 22, 2018 | K173381 | Nexxis OR | DXJ | Substantially Equivalent | Barco N.V. | accessdata.fda.gov |
| September 26, 2017 | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM | LLZ | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 30, 2017 | K163505 | ARIETTA PRECISION | IYN | Substantially Equivalent | Hitachi , Ltd. | accessdata.fda.gov |
| April 13, 2015 | K142647 | mint Lesion | LLZ | Substantially Equivalent | Mint Medical GmbH | accessdata.fda.gov |
| March 20, 2014 | K132436 | VARIOGUIDE DRILL KIT | HBE | Substantially Equivalent | Mri Interventions, Inc. | accessdata.fda.gov |
| September 26, 2013 | K131431 | AIRO CT SYSTEM | JAK | Substantially Equivalent | Mobius Imaging, LLC | accessdata.fda.gov |
| August 16, 2013 | K123605 | SMARTFLOW CATHETER | HCA | Substantially Equivalent | Mri Interventions, Inc. | accessdata.fda.gov |
| April 26, 2013 | K122225 | STERILE RADIOLUCENT SKULL PINS | HBL | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| April 22, 2013 | K122167 | NEXXIS OR | DXJ | Substantially Equivalent | Barco N.V. | accessdata.fda.gov |
| January 15, 2013 | K123788 | INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 14, 2012 | K120789 | EXACTRAC X-RAY X-RAY | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 22, 2012 | K112881 | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) | GWF | Substantially Equivalent | Nexstim OY | accessdata.fda.gov |
| May 7, 2012 | K113732 | IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) | JAK | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| July 14, 2010 | K100038 | DISPOSABLE REFLECTIVE MARKER SPHERES | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 6, 2010 | K092467 | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| March 19, 2008 | K073714 | TRAUMACAD VERSION 2.0 | LLZ | Substantially Equivalent | Orthocrat, Ltd. | accessdata.fda.gov |
| July 25, 2006 | K060808 | BRAINPRO, BRAINPRO ACCESS | HAW | Substantially Equivalent | PAJUNK GmbH Medizintechnologie | accessdata.fda.gov |
| March 23, 2006 | K053164 | IPLAN FLOW | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| February 3, 2006 | K053500 | FRAMELESS RADIOSURGERY COMPONENTS | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| January 27, 2004 | K033621 | NDI PASSIVE SPHERES | HAW | Substantially Equivalent | Northern Digital, Inc. | accessdata.fda.gov |
| March 4, 2002 | K014022 | MRI LINE MARKER | IYE | Substantially Equivalent | I.Z.I. Corp. | accessdata.fda.gov |
| June 5, 1995 | K945903 | BRAINLAB MASK SYSTEM | IYE | Substantially Equivalent | Brainlab Med. Computersysteme GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 10, 2025 | 96241 | Class II | Ongoing | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 | Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification. | accessdata.fda.gov |
| March 2, 2023 | 91781 | Class II | Ongoing | Cirq Arm System 2.0 | Risk of mechanical instability due to potential manufacturing error of the device | accessdata.fda.gov |
| February 14, 2023 | 91664 | Class II | Ongoing | Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F. | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template | accessdata.fda.gov |
| February 25, 2022 | 89662 | Class II | Ongoing | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. | accessdata.fda.gov |
| May 14, 2021 | 87984 | Class II | Terminated | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator f | Display of potential patient movement might be delayed to the user for high dose treatments. | accessdata.fda.gov |
| March 1, 2021 | 87395 | Class II | Terminated | ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). | In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values. | accessdata.fda.gov |
| August 31, 2020 | 86438 | Class II | Terminated | Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally in | Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. | accessdata.fda.gov |
| August 20, 2020 | 86272 | Class II | Terminated | Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A) | Holding force of the Positioning Arm can be reduced by prolonged non-use. | accessdata.fda.gov |
| July 16, 2020 | 86046 | Class II | Terminated | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011 | Incorrect manufacturer calibration | accessdata.fda.gov |
| September 25, 2019 | 83978 | Class II | Terminated | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DA | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under | accessdata.fda.gov |
| March 11, 2019 | 82601 | Class II | Terminated | RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS | There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting. | accessdata.fda.gov |
| February 27, 2019 | 82304 | Class I | Terminated | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization sy | In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View, which is commonly used for navigating inv | accessdata.fda.gov |
| February 14, 2018 | 79266 | Class II | Terminated | ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order | The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI. | accessdata.fda.gov |
| November 16, 2017 | 78715 | Class II | Terminated | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left | Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications. | accessdata.fda.gov |
| November 3, 2017 | 78488 | Class II | Terminated | BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intende | Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This dev | accessdata.fda.gov |
| October 27, 2016 | 75548 | Class II | Terminated | Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic | Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing | accessdata.fda.gov |
| May 4, 2016 | 74265 | Class II | Terminated | ExacTrac Vero is a Patient Positioning System for Radiation therapy. | Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 | accessdata.fda.gov |
| November 5, 2015 | 72804 | Class II | Terminated | RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan | Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0. | accessdata.fda.gov |
| September 21, 2015 | 72236 | Class II | Terminated | Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archi | Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. | accessdata.fda.gov |
| August 18, 2015 | 71996 | Class II | Terminated | Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning prob | Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together. | accessdata.fda.gov |
| August 5, 2015 | 71898 | Class II | Terminated | ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radio | ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification. | accessdata.fda.gov |
| May 8, 2015 | 71248 | Class II | Terminated | BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable m | Instances of data sets not being accurately registered to the patient anatomy were observed. | accessdata.fda.gov |
| March 6, 2015 | 70951 | Class II | Terminated | ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. | ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees. | accessdata.fda.gov |
| February 16, 2015 | 70657 | Class II | Terminated | ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. | The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT. | accessdata.fda.gov |
| January 16, 2015 | 70291 | Class II | Terminated | The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument) | The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level. | accessdata.fda.gov |
| November 19, 2014 | 69960 | Class II | Terminated | iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesio | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. | accessdata.fda.gov |
| June 27, 2014 | 68737 | Class II | Terminated | Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer | The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels | accessdata.fda.gov |
| June 24, 2014 | 68741 | Class II | Terminated | ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tum | When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered t | accessdata.fda.gov |
| May 21, 2014 | 68845 | Class II | Terminated | Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor syste | Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the gantry position of the scanner. The gantry position can either be entered manually or submitted automatically from the CT scanner. If automatic gantry communication i | accessdata.fda.gov |
| April 15, 2014 | 67926 | Class II | Terminated | ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. | When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient. | accessdata.fda.gov |
| February 24, 2014 | 67719 | Class II | Terminated | ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 4993 | When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position. | accessdata.fda.gov |
| November 18, 2013 | 67569 | Class II | Terminated | Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264 | The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in | accessdata.fda.gov |
| November 15, 2013 | 67017 | Class II | Terminated | BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual comp | Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particle | accessdata.fda.gov |
| July 16, 2013 | 65773 | Class II | Terminated | BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedu | The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap. | accessdata.fda.gov |
| April 22, 2013 | 71924 | Class I | Terminated | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable mi | Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy. | accessdata.fda.gov |
| August 12, 2009 | 52988 | Not yet classified | Terminated | BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 - Circular ARC SRS/SRT Planning. The software is intended for us | Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient. | accessdata.fda.gov |
| March 19, 2009 | 51484 | Not yet classified | Terminated | BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany. The mMLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target v | The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment. | accessdata.fda.gov |
| November 12, 2007 | 48682 | Not yet classified | Terminated | VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapellenstrasse 12, 85622 F | Diameter of cables used for installation are to small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in overheating cables. | accessdata.fda.gov |
| June 5, 2007 | 38170 | Not yet classified | Terminated | BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software,; BrainLab AG, Ammerthalstrasse 8, 85551 H | Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment. | accessdata.fda.gov |
| June 2, 2006 | 35742 | Not yet classified | Terminated | ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device | During ExacTrac Robotics installation on the Varian Exact Couch, the couch height position indication is re-calibrated to read out the correct positions. This re-calibration could cause the eventual failure of the vertical lift mechanism of the couch, which might result in patient injury or death. | accessdata.fda.gov |
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Updated October 5, 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.