The Recall Desk

Manufacturer

Siemens Medical Solutions USA, Inc

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

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.

26–50 of 156

  • SevereFDA (Devices)·Z-2665-2025·2025-10-08

    Siemens MAGNETOM Verio Dot MRI Systems Recalled for Helium Leak Risk

    Siemens is recalling 59 MAGNETOM Verio Dot MRI systems due to potential ice blockage in the helium venting system. This could cause pressure buildup and helium leak into the scanning room.

    Product
    MAGNETOM Verio Dot. Model Number: 10684333.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2661-2025·2025-10-08

    Siemens MRI Helium Containment Rupture Risk from Vent Blockage

    Siemens MAGNETOM Skyra fit MRI systems may have ice blockage in the venting system preventing helium gas escape during quench events, risking containment rupture and helium leak into the scanning room.

    Product
    MAGNETOM Skyra fit. Model Number: 10849580.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2668-2025·2025-10-08

    MRI Scanner Helium Venting System May Leak Due to Ice Blockage

    Siemens MAGNETOM Vida Fit MRI scanners may develop ice blockages in the helium venting system. During a quench event, blocked vents could cause helium pressure buildup and rupture, leading to helium leaks into the scanning room.

    Product
    MAGNETOM Vida Fit. Model Number: 11410481.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2529-2025·2025-09-17

    Fluoroscopic X-Ray System Recalled for Limited Movement After Startup

    Siemens is recalling 20 Artis Pheno fluoroscopic X-ray systems due to limited movement after startup. The issue affects specific serial numbers across multiple US states.

    Product
    Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2025·2025-07-09

    Siemens Interventional X-ray System May Misreport Radiation Dose

    Siemens interventional fluoroscopic x-ray systems may fail to correctly measure and report radiation dose due to rare sensor-software communication failures. The worldwide recall affects healthcare facilities using these systems.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2021-2025·2025-07-09

    Interventional fluoroscopic x-ray system may incorrectly report radiation dose

    Siemens interventional x-ray systems may fail to correctly report radiation dose in very rare cases due to sensor-software communication failures. When this occurs, the system incorrectly reports high-dose readings.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2022-2025·2025-07-09

    Siemens Interventional Fluoroscopic X-Ray System Dose Reporting Failure

    Siemens interventional fluoroscopic x-ray systems may fail to accurately report applied radiation dose in rare situations due to sensor-software communication failures, potentially providing inaccurate dose information to clinical staff.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2019-2025·2025-07-09

    Siemens ARTIS Angiography Systems Recalled for Rare Dose Reporting Error

    Siemens recalled its ARTIS angiography systems worldwide due to rare communication failures between dose sensors and software that may cause incorrect dose reporting. No illnesses or injuries have been reported.

    Product
    ARTIS 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 ARTIS family include cardiac angiography,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1982-2025·2025-06-25

    UROSKOP Omnia Max Recalled for Fire Risk from Overheating Resistor

    Siemens is recalling 25 UROSKOP Omnia Max imaging devices nationwide because a resistor in the frequency inverter may overheat, potentially igniting the plastic housing.

    Product
    UROSKOP Omnia Max. Model Number: 10762473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2025·2025-06-25

    UROSKOP Omnia Medical Imaging Device Recalled for Fire Hazard

    Siemens Medical Solutions is recalling 95 units of the UROSKOP Omnia medical imaging device nationwide due to a resistor in the frequency inverter that may overheat and ignite the plastic housing. No injuries have been reported.

    Product
    UROSKOP Omnia. Model Number: 10094910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2025·2025-02-05

    X-Ray System Recalled for Potential Excessive Radiation Dose in First Image

    Siemens ARTIS One X-ray systems may deliver higher radiation doses during first imaging after patient registration due to copper prefiltration malfunction occurring in very rare situations.

    Product
    ARTIS One Angiographic X-Ray System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2528-2024·2024-08-14

    Multitom Rax X-Ray Systems Support Arm May Lower Unexpectedly

    The support arm on Siemens Multitom Rax X-ray systems may unintentionally lower, creating a fall risk to people positioned beneath the ceiling-mounted display during system positioning.

    Product
    Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2024·2024-08-14

    Luminos dRF Max X-ray Display Support Arm May Unintentionally Lower

    Siemens recalled 24 units of the Luminos dRF Max X-ray display system because the support arm may unintentionally lower, potentially injuring personnel positioned beneath the equipment.

    Product
    Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2024·2024-08-14

    Medical X-ray display system support arm may lower unexpectedly

    Siemens LUMINOS Lotus Max X-ray displays are being recalled because the support arm may lower unintentionally, potentially injuring people nearby during positioning.

    Product
    LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2024·2024-08-14

    Siemens x-ray display system support arm may lower unexpectedly

    Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.

    Product
    Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2438-2024·2024-07-31

    Sensis Vibe diagnostic systems software crash during event documentation

    Siemens Sensis Vibe diagnostic systems may crash when using documentation features during once-per-study event reporting. Three systems are affected; no injuries reported.

    Product
    Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as wel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2024·2024-07-31

    Sensis Vibe Cardiac Imaging System Software May Crash During Documentation

    Siemens' Sensis Vibe cardiac imaging system software may crash when documentation functionality is used during diagnostic event recording. Two affected systems have been recalled nationwide.

    Product
    Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as intervention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2024·2024-07-31

    Sensis Vibe medical diagnostic system software crashes during documentation events

    A software issue in certain Siemens Sensis Vibe diagnostic systems may cause the application to crash when documentation features are used during clinical reporting events.

    Product
    Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2024·2024-07-31

    Medical device diagnostic software vulnerability causes potential application crashes

    Siemens Sensis Vibe diagnostic systems may crash when documentation functionality is used during certain reporting events. Seven units were distributed to facilities nationwide.

    Product
    Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2024·2024-07-03

    Siemens X-ray Table Recalled for Fire Hazard in Power Supply

    Siemens recalls AXIOM MULTIX MT radiographic X-ray tables due to a short circuit in the power supply unit that may cause overheating and fire. 7 units are affected nationwide.

    Product
    AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2182-2024·2024-07-03

    Radiographic X-ray Table Recalled Due to Fire Hazard in Power Supply

    Siemens AXIOM MULTIX MP radiographic X-ray tables are being recalled due to a potential short circuit in the touch display's power supply unit that may cause overheating or fire. 12 units nationwide are affected.

    Product
    AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2024·2024-07-03

    Siemens Multix TOP X-ray Table Recalled Due to Fire Risk

    Siemens is recalling 3 Multix TOP I PRO radiographic X-ray tables due to a short circuit in the Touch Display power supply unit that may cause overheating and fire.

    Product
    MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2024·2024-07-03

    X-ray table recalled for fire hazard from power supply unit short circuit

    Siemens MULTIX TOP I PRO X-ray tables are recalled due to a power supply short circuit that may cause overheating and fire. Three units have been identified.

    Product
    MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 475525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2024·2024-07-03

    AXIOM Vertix Solitaire Medical Imaging Device Recall: Fire Risk from Power Supply Defect

    Siemens is recalling 4 AXIOM Vertix Solitaire medical imaging devices due to a short circuit in the touch display power supply that may cause overheating and fire. Units with serial numbers 1004, 1006, 1011, and 1014 are affected.

    Product
    AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2184-2024·2024-07-03

    Medical imaging system recalled for power supply fire risk

    Siemens is recalling 2 AXIOM Vertix MD imaging systems nationwide due to a potential fire hazard from a short circuit in the power supply unit that may cause overheating.

    Product
    AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
    Category
    Medical Device
    Distribution
    Distributed nationwide