The Recall Desk

Manufacturer

Siemens Medical Solutions USA, Inc.

796 recalls in our database name Siemens Medical Solutions USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
796
Critical
16
Severe
69
Most recent
2026-07-08

Of the 796 recalls from Siemens Medical Solutions USA, Inc. we have scored against our rubric, 16 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 69 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

501–525 of 796

  • HighFDA (Devices)·Z-0605-2017·2016-11-23

    Siemens SOMATOM CT Systems Recalled for Loose Light Marker Windows

    Siemens is recalling SOMATOM Definition AS and Flash CT systems because light marker windows may become loose or drop out, creating a risk of contact with rotating or electrical parts.

    Product
    SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0601-2017·2016-11-23

    Siemens Artis Q Angiographic X-ray System Recalled for Footswitch Defect

    Siemens is recalling 4,657 Artis Q angiographic x-ray systems because the semi-automatic focus switch may not work as intended when the footswitch is pressed multiple times.

    Product
    Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2017·2016-11-23

    Siemens Recalls CT Systems for Software Safety Bug Fixes

    Siemens is releasing a software update for specific CT systems to correct potential safety issues and improve performance.

    Product
    SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at diffe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2017·2016-11-23

    Siemens Recalls SOMATOM Definition AS CT Systems for Software Update

    Siemens is recalling seven SOMATOM Definition AS CT systems to install a software update that fixes bugs and corrects potential safety issues.

    Product
    SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at differe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0373-2017·2016-11-16

    Siemens SOMATOM Definition AS CT Systems Recalled for Injury Risk

    Siemens Medical Solutions is recalling 57 SOMATOM Definition AS CT systems due to a hardware issue that may expose users to rotating or electrical parts.

    Product
    SOMATOM Definition AS system, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0374-2017·2016-11-16

    Siemens SOMATOM Definition Flash CT Systems Recalled for Injury Risk

    Siemens is recalling 57 SOMATOM Definition Flash CT systems in the US due to a hardware issue that may expose users to rotating or electrical parts.

    Product
    SOMATOM Definition Flash system, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2017·2016-10-19

    Siemens Symbia T Series SPECT + CT Recall for Bearing Failure Risk

    Siemens Medical Solutions is recalling 1,109 Symbia T Series SPECT + CT systems because linear bearing cars may fail, allowing ball bearings to fall out.

    Product
    Symbia T Series SPECT + CT 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 energies up to 588 keV. 2) CT: The CT compon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2017·2016-10-19

    Siemens Symbia S Camera Systems Recalled for Bearing Failure Risk

    Siemens Medical Solutions is recalling Symbia S camera systems because linear bearing cars may fail, allowing ball bearings to fall out.

    Product
    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 energies up to 588 keV. 2) CT: The CT component is intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2017·2016-10-12

    Siemens Recalls Multix Fusion X-Ray Systems Due to Table Tilt Risk

    Siemens is recalling 37 Multix Fusion X-ray systems because an internal table part may detach, causing the table to tilt and potentially injure patients.

    Product
    Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2017·2016-10-12

    Siemens Recalls Ysio Max Radiographic Systems Due to Table Tilt Risk

    Siemens is recalling 37 Ysio Max radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.

    Product
    YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2017·2016-10-12

    Siemens Recalls Multix Fusion VA10 Radiographic Systems Due to Table Defect

    Siemens is recalling 37 Multix Fusion VA10 radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.

    Product
    Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on pediat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2876-2016·2016-10-05

    Siemens ARTISTE Linear Accelerators Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling 103 ARTISTE linear accelerators to install a software patch addressing several safety issues.

    Product
    ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2878-2016·2016-10-05

    Siemens Syngo RT Therapist Software Recalled for Safety Issues

    Siemens Medical Solutions is recalling Syngo RT Therapist software to address several safety issues. The recall affects 103 linear accelerators nationwide.

    Product
    Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positionin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2877-2016·2016-10-05

    Siemens PRIMUS Linear Accelerators Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling 103 PRIMUS linear accelerators to install a software patch addressing several safety issues.

    Product
    PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2016·2016-10-05

    Siemens Syngo.plaza PACS Software Recall for Multiple Issues

    Siemens Medical Solutions is recalling 47 Syngo.plaza Picture Archiving and Communication System units to address several software issues.

    Product
    Syngo.plaza, Picture Archiving and Communication System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2892-2016·2016-10-05

    Siemens Medical Solutions Recalls Syngo.plaza VB10A Picture Archiving Systems

    Siemens Medical Solutions USA, Inc. is recalling 47 Syngo.plaza VB10A Picture Archiving and Communication Systems to eliminate several software issues.

    Product
    Syngo.plaza VB10A, Picture Archiving and Communication System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2852-2016·2016-09-28

    Siemens Syngo.x Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 338 Syngo.x PACS systems because a software error caused volume calculations for prostate and liver to be too high.

    Product
    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2853-2016·2016-09-28

    Siemens Syngo.via Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 338 Syngo.via systems because a software error caused volume calculations for prostate and liver to be too high.

    Product
    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2793-2016·2016-09-21

    Siemens Syngo Plaza PACS Recall for Measurement Display Suffix

    Siemens is recalling 101 Syngo Plaza PACS systems because a suffix on DICOM images may indicate that displayed measurements differ from actual values.

    Product
    Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2794-2016·2016-09-21

    Siemens Syngo.Plaza VB 10 A PACS Recall for Measurement Suffix Display

    Siemens is recalling 101 Syngo.Plaza VB 10 A image processing systems because a suffix on DICOM images may indicate that displayed measurement values differ from real values.

    Product
    Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2016·2016-09-14

    Siemens e.cam and Symbia E Gamma Camera Patient Bed Recall

    Siemens is recalling e.cam and Symbia E gamma camera systems because patient hair can become caught in the patient bed drive mechanism.

    Product
    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 for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2016·2016-08-31

    Siemens CT Scanner Recall Due to Contrast Injection Failure

    Siemens is recalling one SOMATOM Definition AS CT scanner because a software error prevents the automatic injection of contrast agent during scans.

    Product
    SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2626-2016·2016-08-31

    Siemens SOMATOM Definition Edge CT Systems Recalled for Injector Failure

    Siemens is recalling four CT systems because a software error prevents the contrast agent injector from starting in automatic or coupled modes.

    Product
    SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2625-2016·2016-08-31

    Siemens CT Scanner Recall Due to Contrast Injection Failure

    Siemens is recalling two CT scanners where a software error prevents contrast agent injection during automatic scans, resulting in failed examinations.

    Product
    SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2394-2016·2016-08-17

    Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Contamination

    Siemens is recalling AXIOM Artis angiography systems because biomass contaminants in the cooling system may damage the pump.

    Product
    ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese p
    Category
    Medical Device
    Distribution
    Distributed nationwide