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Siemens Medical Solutions USA Recalls
796 recalls on record · August 1, 2012 to July 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 8, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MAGNETOM Connectom.X. Model Number: 11371480.
Hazard: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
October 8, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MAGNETOM Cima.X (DE). Model Number: 11647158.
Hazard: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
October 8, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls BIOGRAPH One (DE). Model Number: 11689172.
Hazard: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
October 8, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Biograph mMR. Model Number: 10433372.
Hazard: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
September 17, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Hazard: Limited system movements after startup .
July 9, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
Hazard: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
July 9, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
Hazard: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
July 9, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
Hazard: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
July 9, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention
Hazard: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
June 25, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls UROSKOP Omnia Max. Model Number: 10762473
Hazard: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
June 25, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls UROSKOP Omnia. Model Number: 10094910
Hazard: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
February 5, 2025Medical DevicesFDA
SIEMENS MEDICAL SOLUTIONS USA, INC recalls ARTIS One Angiographic X-Ray System
Hazard: A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
October 2, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultraso
Hazard: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
October 2, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Hazard: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
October 2, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.
Hazard: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
August 14, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Num
Hazard: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
August 14, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Mode
Hazard: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
August 14, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model
Hazard: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
August 14, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Mod
Hazard: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
July 31, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting h
Hazard: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
July 31, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended
Hazard: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
July 31, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be u
Hazard: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
July 31, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a dia
Hazard: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
July 3, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emerge
Hazard: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
July 3, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the
Hazard: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
July 3, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the
Hazard: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
July 3, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients
Hazard: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
July 3, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as wel
Hazard: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
July 3, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a
Hazard: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
July 3, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO
Hazard: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire