The Recall Desk

Manufacturer

Siemens Medical Solutions USA, Inc

162 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 162

  • Severity pendingFDA (Devices)·Z-2659-2025·2025-10-08

    MAGNETOM Prisma. Model Number: 10849582.

    Pending LLM rewrite. Source: FDA_DEVICE Z-2659-2025.

    Product
    MAGNETOM Prisma. Model Number: 10849582.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2654-2025·2025-10-08

    Biograph mMR. Model Number: 10433372.

    Pending LLM rewrite. Source: FDA_DEVICE Z-2654-2025.

    Product
    Biograph mMR. Model Number: 10433372.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2662-2025·2025-10-08

    MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

    Pending LLM rewrite. Source: FDA_DEVICE Z-2662-2025.

    Product
    MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2665-2025·2025-10-08

    MAGNETOM Verio Dot. Model Number: 10684333.

    Pending LLM rewrite. Source: FDA_DEVICE Z-2665-2025.

    Product
    MAGNETOM Verio Dot. Model Number: 10684333.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2666-2025·2025-10-08

    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

    Pending LLM rewrite. Source: FDA_DEVICE Z-2666-2025.

    Product
    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2655-2025·2025-10-08

    BIOGRAPH One (DE). Model Number: 11689172.

    Pending LLM rewrite. Source: FDA_DEVICE Z-2655-2025.

    Product
    BIOGRAPH One (DE). Model Number: 11689172.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2657-2025·2025-10-08

    MAGNETOM Connectom.X. Model Number: 11371480.

    Pending LLM rewrite. Source: FDA_DEVICE Z-2657-2025.

    Product
    MAGNETOM Connectom.X. Model Number: 11371480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2025·2025-07-09

    Siemens Interventional Fluoroscopic X-Ray System Software Communication Failure

    Siemens interventional fluoroscopic x-ray systems may fail to communicate dose information between sensor and software, causing incorrect high-dose reporting. The manufacturer is recalling affected units worldwide.

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

    interventional fluoroscopic x-ray system

    Pending LLM rewrite. Source: FDA_DEVICE Z-2022-2025.

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

    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imag

    Pending LLM rewrite. Source: FDA_DEVICE Z-2019-2025.

    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
  • Severity pendingFDA (Devices)·Z-2021-2025·2025-07-09

    interventional fluoroscopic x-ray system

    Pending LLM rewrite. Source: FDA_DEVICE Z-2021-2025.

    Product
    interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1982-2025·2025-06-25

    Siemens UROSKOP Omnia Max frequency inverter fire risk recalled

    Siemens is recalling UROSKOP Omnia Max medical devices due to a resistor in the frequency inverter that may overheat and ignite the plastic housing. Twenty-five units distributed nationwide are affected.

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

    UROSKOP Omnia X-ray System Model 10094910 Frequency Inverter Overheating Recall

    Siemens is recalling 95 units of the UROSKOP Omnia X-ray system nationwide due to a resistor in the frequency inverter that may overheat and potentially ignite the plastic housing.

    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-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-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-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-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-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-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-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