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.

576–600 of 796

  • HighFDA (Devices)·Z-1520-2016·2016-04-27

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Bugs

    Siemens Medical Solutions is recalling 1,096 CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1519-2016·2016-04-27

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bugs

    Siemens is recalling 1,096 SOMATOM Definition AS CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1350-2016·2016-04-20

    Siemens Recalls One CT System Due to Front Cover Welding Defect

    Siemens is recalling one SOMATOM Definition AS CT system because a front cover weld defect could cause a bolt to break during service, though no clinical risk exists.

    Product
    SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1349-2016·2016-04-13

    Siemens PACS Software Recall for Incorrect Distance Measurements

    Siemens Medical Solutions is recalling 49 PACS systems because they may display incorrect distance measurements when used with certain modalities and syngo Imaging.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1305-2016·2016-04-06

    Siemens Recalls SOMATOM CT Systems Due to Cardio License Malfunction

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction in cardio licenses that could hazard patients and personnel.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2016·2016-04-06

    Siemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee/zeego angiography systems because a cooling system leak could cause equipment failure.

    Product
    AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: 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 pati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2016·2016-04-06

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

    Siemens is recalling 1,757 AXIOM Artis angiography systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.

    Product
    AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2016·2016-04-06

    Siemens Recalls Cios Alpha X-Ray Systems Due to Electrical Shock Risk

    Siemens is recalling four Cios Alpha mobile X-ray systems because a defective part could increase the risk of electrical shock for service personnel during maintenance.

    Product
    CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2016·2016-04-06

    Siemens Artis zeego X-ray Systems Recalled for Mechanical and Electrical Defects

    Siemens is recalling 552 Artis zeego angiography systems due to risks of mechanical cable damage and high-voltage generator module failure.

    Product
    system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and ob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1284-2016·2016-04-06

    Siemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee/zeego angiography systems because a cooling system leak could cause equipment failure.

    Product
    AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: 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 pati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2016·2016-04-06

    Siemens Recalls Cios Alpha Mobile X-Ray Systems Due to Software Issues

    Siemens Medical Solutions is recalling 89 Cios Alpha mobile X-ray systems due to software issues. The units were distributed nationwide to 30 states.

    Product
    Cios Alpha, mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems 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 spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1263-2016·2016-04-06

    Siemens Symbia Gamma Camera Recall for Collimator Change Instructions

    Siemens is recalling 726 Symbia gamma camera systems worldwide to provide supplemental instructions clarifying the proper collimator change procedure.

    Product
    The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same ax
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1262-2016·2016-04-06

    Siemens E.CAM Gamma Camera Recall for Collimator Change Instructions

    Siemens is recalling 3,090 E.CAM gamma camera systems to provide supplemental instructions and visual aids for proper collimator changes.

    Product
    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) and physiologic functions within the human body
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1311-2016·2016-04-06

    Siemens Artis zee/zeego X-Ray Systems Recalled for Cooling System Leak

    Siemens is recalling 1,757 Artis zee/zeego angiographic X-ray systems because a possible leak in the cooling system could allow fluids to seep into the equipment cabinet.

    Product
    Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2016·2016-04-06

    Siemens Artis One X-Ray System Recalled for Data Mirroring Error

    Siemens is recalling one Artis One angiography system because imported left atrium segmentation results may be incorrectly mirrored to a 3D mapping system.

    Product
    Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1232-2016·2016-03-30

    Siemens syngo X Workplace Medical Workstation Recalled for Segmentation Error

    Siemens Medical Solutions USA is recalling six syngo X Workplace medical workstations because imported segmentation results appear mirrored, rendering them unusable for ablation procedures.

    Product
    syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2016·2016-03-23

    Siemens Syngo Dynamics PACS Software Recall for Measurement Package Issue

    Siemens is recalling Syngo Dynamics PACS software due to a potential issue in the VA10 measurement package. 228 units are affected nationwide.

    Product
    Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2016·2016-03-02

    Siemens Mammomat Inspiration Recall for Potential System Fatal Error

    Siemens is recalling 76 Mammomat Inspiration units because a system fatal error may occur during tomosynthesis reconstruction for large breasts, causing the process to abort.

    Product
    Mammomat Inspiration with Tomosynthesis functionality
    Category
    Medical Device
    Distribution
    Distributed nationwide