Data / Medical devices / United States / Siemens Medical Solutions Usa, Inc.
Siemens Medical Solutions Usa, Inc.: FDA-registered device maker in Hoffman Estates, IL, United States, 42 510(k) clearances
Siemens Medical Solutions Usa, Inc. is registered with the FDA (registration 1423253) in Hoffman Estates, IL, United States. It lists 6 device types. The FDA files 42 510(k) clearances under its listings, the newest dated May 21, 2026. 42 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1423253
- FEI number
- 1000514697
- Address
- 2501 North Barrington RD., Hoffman Estates, IL, United States, 60192
- Owner or operator
- SIEMENS MEDICAL SOLUTIONS USA, INC. (9002915)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer
- First device listed
- December 26, 2012
- Registered through
- 2026
- Brand names listed
- B.brilliant, BIograph mCT S, Biograph 16 TP-3R, Biograph 16 TP-4R, Biograph 16 TruePoint, Biograph 16 TruePoint w/TrueV, Biograph 40 TP-3R, Biograph 40 TP-4R and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Digital Breast Tomosynthesis | OTE | 3 | Contract manufacturer | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer, Remanufacturer | 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 |
|---|---|---|---|---|---|---|
| May 21, 2026 | K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 10, 2026 | K254016 | MI View&GO | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 31, 2025 | K251561 | Biograph Trinion | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 3, 2025 | K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 3, 2025 | K251528 | syngo.via MI Workflows; Scenium; syngo MBF | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 30, 2024 | K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 30, 2024 | K242300 | MI View&GO | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 30, 2024 | K242275 | syngo.via MI Workflows; Scenium; syngo MBF | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 26, 2024 | K241898 | Symbia SPECT and SPECT/CT Systems | KPS | Substantially Equivalent | Siemens Healthineers | accessdata.fda.gov |
| January 12, 2024 | K233677 | Biograph VK10 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 28, 2023 | K232000 | syngo.via MI Workflows; Scenium; syngo MBF | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 13, 2023 | K231833 | Biograph Vision.X and Biograph Vision.X Edge | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 17, 2023 | K231102 | Symbia Pro.specta VA20A Family | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 22, 2022 | K223547 | Biograph Vision Quadra PET/CT System | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 19, 2022 | K222172 | MI View&GO | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 16, 2021 | K212604 | Symbia VA10A Family | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 10, 2021 | K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | QIH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 12, 2021 | K210557 | Symbia VA10A Family | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 3, 2021 | K210262 | Biograph Vision Quadra PET/CT System | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 20, 2020 | K200474 | Symbia 6.7 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 14, 2020 | K193248 | Biograph Vision, Biograph mCT Family of PET/CTs | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 12, 2020 | K193178 | Biograph Horizon | KPS | Substantially Equivalent | Siemens Medical Solution USA, Inc. | accessdata.fda.gov |
| July 19, 2019 | K191309 | syngo.via MI Workflows VB40A, Scenium | LLZ | Substantially Equivalent | Siemens Medical Soultions USA, Inc. | accessdata.fda.gov |
| May 6, 2019 | K190900 | Biograph Vision | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 23, 2018 | K180811 | Biograph Vision | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 5, 2018 | K173897 | syngo.via MI Workflows | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 4, 2018 | K173597 | Scenium VE20 Software | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 20, 2017 | K173578 | Biograph mCT Family of PET/CT Systems | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 1, 2017 | K170904 | Biograph Horizon PET/CT | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 9, 2017 | K162483 | Symbia Intevo Bold | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 3, 2017 | K163421 | syngo.via MI Workflows | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 21, 2016 | K162339 | Scenium | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 8, 2016 | K162337 | Symbia 6.5 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 12, 2016 | K152880 | Biograph Horizon PET/CT | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 17, 2015 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 23, 2015 | K151192 | syngo.via MI Workflows | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 29, 2015 | K150192 | Scenium | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 12, 2014 | K141971 | BIOGRAPH TRUE PET/CT FAMILY SOFTWARE | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 21, 2014 | K142006 | SYMBIA 6.0 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 25, 2014 | K133644 | SYNGO.VIA MI WORKFLOWS | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 6, 2011 | K110494 | SYNGO MBF | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 20, 2003 | K031825 | C.CAM | KPS | Substantially Equivalent | Danish Diagnostic Development A/S | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 12, 2023 | 92704 | Class II | Ongoing | The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) | During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution. | accessdata.fda.gov |
| January 16, 2023 | 91518 | Class II | Ongoing | SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission | This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. | accessdata.fda.gov |
| March 11, 2022 | 89790 | Class II | Terminated | Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems | There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue. | accessdata.fda.gov |
| August 14, 2020 | 86262 | Class II | Terminated | Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body | This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk. | accessdata.fda.gov |
| November 30, 2018 | 81821 | Class II | Terminated | Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high | Improper design or specifications. | accessdata.fda.gov |
| October 5, 2018 | 80927 | Class II | Terminated | EVO Excel, Emission Computed Tomographic System, Material Number 10910501 | The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A. | accessdata.fda.gov |
| September 28, 2018 | 81144 | Class II | Terminated | Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) sc | The terminals on the plug may become loose and overheat. | accessdata.fda.gov |
| May 29, 2018 | 80200 | Class II | Terminated | Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography | Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems. | accessdata.fda.gov |
| February 21, 2018 | 80071 | Class II | Terminated | Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module. | accessdata.fda.gov |
| January 26, 2018 | 79988 | Class II | Terminated | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. | Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative | accessdata.fda.gov |
| November 7, 2017 | 78184 | Class II | Terminated | Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomogr | The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered. | accessdata.fda.gov |
| September 18, 2017 | 78086 | Class II | Terminated | Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices. | The torque wrench used to tighten system bolts during installation was found to be out of tolerance | accessdata.fda.gov |
| August 5, 2016 | 74395 | Class II | Terminated | e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging | "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for your e.cam or Symbia E system and to inform you of an update that will be performed by your local Siemens service representative." | accessdata.fda.gov |
| March 31, 2016 | 86230 | Class II | Terminated | E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomogra | E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is remote. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomog | accessdata.fda.gov |
| February 26, 2016 | 73504 | Class II | Terminated | The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) an | We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and | accessdata.fda.gov |
| December 31, 2015 | 73038 | Class II | Terminated | The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for is | To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer. | accessdata.fda.gov |
| July 31, 2015 | 71867 | Class II | Terminated | Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly. | accessdata.fda.gov |
| June 26, 2015 | 72296 | Class II | Terminated | e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, to | Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized. | accessdata.fda.gov |
| August 12, 2014 | 69114 | Class II | Terminated | The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries. | accessdata.fda.gov |
| July 28, 2014 | 68932 | Class II | Terminated | The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be u | Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead t | accessdata.fda.gov |
| April 23, 2014 | 68632 | Class II | Terminated | e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic ima | Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose. | accessdata.fda.gov |
| April 8, 2014 | 69992 | Class II | Terminated | e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isoto | There is a potential for patient finger injury on the e.cam systems. | accessdata.fda.gov |
| March 5, 2014 | 69995 | Class II | Terminated | Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. | There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components. | accessdata.fda.gov |
| October 28, 2013 | 66778 | Class II | Terminated | Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ. | Reports of loose bolts in the detector support structure of Symbia and E.CAM systems. | accessdata.fda.gov |
| August 16, 2013 | 66544 | Class II | Terminated | Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energ | The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. | accessdata.fda.gov |
| October 23, 2012 | 70259 | Class II | Terminated | The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced | There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. | accessdata.fda.gov |
| May 15, 2012 | 61672 | Not yet classified | Terminated | Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging, whole- | Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not eng | accessdata.fda.gov |
| April 11, 2012 | 70246 | Class II | Terminated | Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotope | Radial motor drives replaced during a customer service action were incorrectly assembled backwards. | accessdata.fda.gov |
| October 14, 2011 | 60142 | Not yet classified | Terminated | Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtai | Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems. | accessdata.fda.gov |
| June 22, 2011 | 58918 | Not yet classified | Terminated | Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet is used for performing S | There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient. | accessdata.fda.gov |
| December 11, 2009 | 53919 | Not yet classified | Terminated | Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies wi | Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities. | accessdata.fda.gov |
| April 22, 2009 | 52091 | Not yet classified | Terminated | Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for use: SPECT + CT: Perform scans and nuclear imaging studies wit | The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan. | accessdata.fda.gov |
| March 11, 2009 | 51483 | Not yet classified | Terminated | Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741. | Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.e. the patient or pallet is into the fiel | accessdata.fda.gov |
| December 18, 2008 | 50773 | Not yet classified | Terminated | Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left). | Patient fingers can get pinched if they attempt to pull themselves up from the patient handling system without any assistance and grabbing onto the flip-up FOV indicator bars. | accessdata.fda.gov |
| September 29, 2008 | 49456 | Not yet classified | Terminated | Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to perform CT scans and nuc | The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard. | accessdata.fda.gov |
| September 17, 2007 | 44913 | Not yet classified | Terminated | c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark | Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard. | accessdata.fda.gov |
| April 30, 2007 | 37857 | Not yet classified | Terminated | c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203; Made in Denmark | Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use. | accessdata.fda.gov |
| January 30, 2007 | 37231 | Not yet classified | Terminated | Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; pa | Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. | accessdata.fda.gov |
| September 5, 2003 | 27105 | Not yet classified | Terminated | e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 | The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator. | accessdata.fda.gov |
| February 10, 2003 | 25546 | Not yet classified | Terminated | e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 | Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions. | accessdata.fda.gov |
| February 10, 2003 | 25544 | Not yet classified | Terminated | Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203 | Unintended yoke rotational motion. | accessdata.fda.gov |
| February 10, 2003 | 25541 | Not yet classified | Terminated | ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 | ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions. | accessdata.fda.gov |
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Updated May 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.