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.

426–450 of 796

  • HighFDA (Devices)·Z-0405-2018·2018-01-31

    Siemens Syngo Imaging PACS Recalled for Potential Data Loss

    Siemens is recalling 36 units of Syngo Imaging version V31 software due to a potential risk of data loss relevant to diagnosis.

    Product
    Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2018·2017-11-29

    Siemens Recalls Syngo.plaza PACS Software Due to Image Count Discrepancy

    Siemens Medical Solutions is releasing a software tool to fix an issue where Syngo.plaza PACS displays fewer de-archived images than archived.

    Product
    Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the ph
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0094-2018·2017-11-22

    Siemens Symbia Intevo 6 SPECT/CT Software Recall for Data Input Error

    Siemens is recalling two Symbia Intevo 6 SPECT/CT systems because a software option may prevent users from modifying specific data input values during calibration.

    Product
    Symbia Intevo 6, 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, tomographic imaging for isotopes with energies up to 588keV. SPECT
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0093-2018·2017-11-22

    Siemens Symbia Intevo 16 SPECT/CT Software Recall for Data Input Error

    Siemens is recalling two Symbia Intevo 16 SPECT/CT systems because a software option may prevent users from modifying specific data input values.

    Product
    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, tomographic imaging for isotopes with energies up to 588keV. SPEC
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0047-2018·2017-11-01

    Siemens Medical Solutions Recalls Torque Wrenches for Symbia CT Devices

    Siemens Medical Solutions is recalling 16 torque wrenches used to install Symbia CT scanners because the tools were found to be out of tolerance.

    Product
    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.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3089-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3091-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3096-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3088-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3095-2017·2017-09-06

    Siemens Medical Solutions Recalls AXIOM Artis zee and Q Angiography Systems

    Siemens Medical Solutions is recalling 986 AXIOM Artis zee and Q angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3099-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3098-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3093-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3090-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3094-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen x-ray systems recalled for cooling leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen x-ray systems in the US because a cooling system leak could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3092-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US because a cooling system leak could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3097-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2686-2017·2017-07-26

    Siemens Artis zee X-ray System Recalled for Component Defect

    Siemens is recalling specific Artis zee angiographic x-ray systems due to a component defect that can cause failures.

    Product
    Artis zee,x-ray system, angiographic Artis zee is 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 be performed with the Ar
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2688-2017·2017-07-12

    Siemens Sensis Vibe Systems Recalled for Software Error in Report Generation

    Siemens is recalling 13 Sensis Vibe diagnostic computers in the US due to a software error that may combine patient data from different examinations into a single report.

    Product
    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2156-2017·2017-05-31

    Siemens AXIOM Sensis Diagnostic Computer Recalled for Dust-Related Failures

    Siemens Medical Solutions is recalling 4,095 AXIOM Sensis diagnostic computers because dust accumulation can cause system failures, potentially interrupting clinical treatments.

    Product
    AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1875-2017·2017-05-03

    Siemens ACUSON S Family Ultrasound Systems Recalled for Image Display Defects

    Siemens is recalling 2,045 ACUSON S Family ultrasound systems because the 18L6 HD transducer may display a triple image or a dark band, potentially affecting diagnostic accuracy.

    Product
    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2017·2017-04-26

    Siemens Artis zee Angiographic X-ray System Software Recall

    Siemens is recalling three Artis zee angiographic x-ray systems due to a software fault that prevents the system from initializing after a tube assembly failure.

    Product
    Artis zee, Angiographic x-ray system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1770-2017·2017-04-19

    Siemens Combi Dockable Neurosurgery Table Recalled for Height Drop Risk

    Siemens Medical Solutions is recalling three Combi Dockable Neurosurgery tables for MRI systems due to a potential manufacturing error that could cause a sudden drop in table height.

    Product
    Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1689-2017·2017-04-05

    Siemens Syngo.via Software Recall for Medical Image System Issues

    Siemens Medical Solutions is recalling 104 units of Syngo.via picture archiving software to address several identified issues.

    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. It can be used as a standalone device or together with a variety of cleared and unmodified syngo ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2017·2017-04-05

    Siemens Syngo.x PACS Software Recalled for Addressing Multiple Issues

    Siemens Medical Solutions is recalling 104 Syngo.x PACS systems to install software updates that address several unspecified issues.

    Product
    Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo base
    Category
    Medical Device
    Distribution
    Distributed nationwide