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.

201–225 of 796

  • HighFDA (Devices)·Z-2921-2020·2020-09-09

    Siemens Sensis Vibe Hemo System Recalled for Connector Defect

    Siemens is recalling 110 Sensis Vibe Hemo systems because a connector may break, potentially causing the device to stop functioning and lose vital signs.

    Product
    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2887-2020·2020-09-02

    Siemens Recalls Cios Alpha and Spin X-Ray Systems for Hardware Error

    Siemens is recalling 329 Cios Alpha and Cios Spin mobile X-ray systems due to a hardware error affecting the X-ray generator after a previous repair.

    Product
    Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2888-2020·2020-09-02

    Siemens Recalls Cios Spin and Cios Alpha X-Ray Systems Due to Hardware Error

    Siemens is recalling 329 Cios Spin and Cios Alpha mobile X-ray systems due to a hardware error affecting the X-ray Generator with an integrated Energy Storage Unit.

    Product
    Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2848-2020·2020-09-02

    Siemens Cios Alpha and Spin Mobile X-Ray Systems Recalled for Electrical Malfunction

    Siemens is recalling Cios Alpha and Cios Spin mobile X-ray systems because a hardware error could cause permanent loss of imaging functionality.

    Product
    Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2898-2020·2020-09-02

    Siemens E.cam and Symbia Systems Recalled for Detector Time Loss

    Siemens Medical Solutions is recalling E.cam and Symbia systems with foresight detectors because they may lose detector time information during gated or dynamic acquisitions.

    Product
    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, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2758-2020·2020-08-12

    Siemens Ysio Max X-Ray System Recalled for Software Defects

    Siemens Medical Solutions is recalling 512 Ysio Max X-ray systems due to software issues that may cause collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2020·2020-08-12

    Siemens Uroskop Omnia Max Recalled for Software Collision and Image Errors

    Siemens is recalling 194 Uroskop Omnia Max units due to software issues that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2756-2020·2020-08-12

    Siemens Luminos Agile Max Recalled for Software Collision and Image Errors

    Siemens Medical Solutions is recalling 477 Luminos Agile Max units due to software defects that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2755-2020·2020-08-12

    Siemens Luminos dRF Max Recalled for Software Collision and Image Errors

    Siemens is recalling 49 Luminos dRF Max units due to software defects that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2688-2020·2020-07-29

    Siemens syngo.via RT Image Suite Software Recall for Geometry Errors

    Siemens is recalling syngo.via RT Image Suite software versions VB30 and VB40 because modified MR image orientations may result in incorrect geometry and radiation treatment plans.

    Product
    syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2020·2020-06-24

    Siemens MAMMOMAT Revelation Mammography System Recalled for Biopsy Removal Limitation

    Siemens is recalling MAMMOMAT Revelation mammography systems because a software limitation may make it difficult to remove the vacuum biopsy system if an exam is interrupted.

    Product
    MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2020·2020-06-17

    Siemens Artis X-Ray Systems Recalled for Electrical Contact Issues

    Siemens is recalling 15 Artis X-ray systems in the US because a power distributor defect may cause electrical contact interruptions, leading to procedure termination.

    Product
    Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 1009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2257-2020·2020-06-10

    Siemens ARTIS icono X-Ray Systems Recalled for Incorrect Vessel Quantification

    Siemens is recalling five ARTIS icono X-ray systems because software may fail to detect vessels or provide incorrect measurements, potentially leading to wrong diagnoses.

    Product
    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2128-2020·2020-06-03

    Siemens Cios Spin X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 20 Cios Spin X-Ray systems because unplugging the monitor cable can create unsafe voltage, posing an electrical shock hazard.

    Product
    Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2020·2020-06-03

    Siemens Cios Alpha X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 58 Cios Alpha X-Ray systems because unplugging the monitor cable can expose users to unsafe electrical voltage, posing a shock hazard.

    Product
    Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2020·2020-06-03

    Siemens ARTIS Pheno X-Ray Systems Recalled for Drivetrain Faults

    Siemens is recalling 105 ARTIS Pheno X-ray systems because a drivetrain fault may prevent the C-arm from moving, requiring field service to restore operation.

    Product
    ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: 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
  • SevereFDA (Devices)·Z-1957-2020·2020-05-20

    Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling four Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2020·2020-05-20

    Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 16 Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage and shock.

    Product
    Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2020·2020-05-20

    Siemens Cios Spin Mobile X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 46 Cios Spin mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2020·2020-05-13

    Siemens AXIOM Aristos FX Plus X-Ray System Recalled for Unintended Radiation

    Siemens is recalling 399 AXIOM Aristos FX Plus x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.

    Product
    System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdom
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1764-2020·2020-05-13

    Siemens AXIOM Aristos FX X-Ray System Recalled for Unintended Radiation

    Siemens is recalling 314 AXIOM Aristos FX x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.

    Product
    System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal colum
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1680-2020·2020-04-15

    Siemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk

    Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.

    Product
    PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1679-2020·2020-04-15

    Siemens ONCOR Radiation Therapy Systems Recalled for Potential Dose Overdose

    Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.

    Product
    ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1678-2020·2020-04-15

    Siemens Medical Solutions Recalls MEVATRON Radiation Therapy Systems

    Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation overdose.

    Product
    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1677-2020·2020-04-15

    Siemens ARTISTE MV System Recalled for Radiation Dose Monitoring Safety Interlock Defect

    Siemens is recalling ARTISTE MV Systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation therapy overdose.

    Product
    ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states