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.

26–50 of 796

  • CriticalFDA (Devices)·Z-2660-2025·2025-10-08

    MAGNETOM Skyra MRI systems recalled over ice blockage in venting system

    Siemens is recalling 586 MAGNETOM Skyra (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2657-2025·2025-10-08

    MRI scanner recalled over ice blockage in magnet helium venting system

    A MAGNETOM Connectom.X MRI system is being recalled because an ice blockage in the magnet venting system could prevent helium from escaping during a quench.

    Product
    MAGNETOM Connectom.X. Model Number: 11371480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2663-2025·2025-10-08

    MAGNETOM Spectra MRI systems recalled over helium venting ice blockage

    Siemens is recalling three MAGNETOM Spectra MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2661-2025·2025-10-08

    MAGNETOM Skyra fit MRI systems recalled over magnet vent ice blockage

    Siemens is recalling 56 MAGNETOM Skyra fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Skyra fit. Model Number: 10849580.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2666-2025·2025-10-08

    MAGNETOM Verio Dot Upgrade systems recalled over magnet venting ice blockage

    Siemens is recalling 78 MAGNETOM Verio Dot Upgrade systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2665-2025·2025-10-08

    MAGNETOM Verio Dot systems recalled over magnet venting ice blockage risk

    Siemens is recalling 59 MAGNETOM Verio Dot systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio Dot. Model Number: 10684333.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2658-2025·2025-10-08

    MAGNETOM Lumina MRI systems recalled over helium venting ice blockage risk

    Siemens is recalling 130 MAGNETOM Lumina (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Lumina (DE). Model Number: 11344916.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2659-2025·2025-10-08

    MAGNETOM Prisma MRI systems recalled over helium venting ice blockage

    Siemens is recalling 101 MAGNETOM Prisma MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

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

    Biograph mMR scanners recalled over ice blockage in magnet venting

    Siemens is recalling 27 Biograph mMR systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    Biograph mMR. Model Number: 10433372.
    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
  • ModerateFDA (Devices)·Z-2019-2025·2025-07-09

    ARTIS angiography systems may incorrectly report a high radiation dose

    ARTIS angiography systems are being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.

    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
  • ModerateFDA (Devices)·Z-2022-2025·2025-07-09

    Fluoroscopic x-ray system recalled over dose sensor communication failure

    An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.

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

    Interventional fluoroscopic x-ray systems may incorrectly report a high dose

    An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.

    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-3217-2024·2024-10-02

    Siemens Diagnostic Ultrasound Systems Recalled for Incorrect Unit Conversion

    Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.

    Product
    ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3216-2024·2024-10-02

    ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error

    Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.

    Product
    ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3215-2024·2024-10-02

    Siemens ACUSON Juniper ultrasound systems software unit conversion error

    Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.

    Product
    ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
    Category
    Medical Device
    Distribution
    42 states
  • 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-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-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-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