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Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc Recalls

All product recalls associated with Siemens Medical Solutions USA, Inc.

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Recall Summary

Total Recalls

128

Past Year

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 128 recalls

Artis Pheno X-Ray System (Siemens) – Limited System Movement (2025)

Limited system movements after startup .

Moderate

FDAAug 12, 2025Nationwide• Siemens Medical Solutions USA, Inc

UROSKOP Omnia (Siemens Medical) – Frequency Inverter Fire Risk (2025)

Fire/Burn Risk

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

High

FDAJun 4, 2025Nationwide• Siemens Medical Solutions USA, Inc

UROSKOP Omnia Max (Siemens Medical) – Frequency Inverter Fire Risk (2025)

Fire/Burn Risk

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

123 4...7

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High

FDAJun 4, 2025Nationwide• Siemens Medical Solutions USA, Inc

Interventional X-Ray System (Siemens) – Dose Sensor Error (2025)

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.

Moderate

FDAMay 15, 2025Nationwide• Siemens Medical Solutions USA, Inc

ARTIS Angiography System (Siemens) – Dose Sensor Error (2025)

Moderate

FDAMay 15, 2025Nationwide• Siemens Medical Solutions USA, Inc

ARTIS One X-Ray System (Siemens) – First Release Issue (2025)

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.

Moderate

FDAJan 2, 2025IN• SIEMENS MEDICAL SOLUTIONS USA, INC

ACUSON Juniper Ultrasound (Siemens) - Software Measurement Error (2024)

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

Moderate

FDAAug 15, 2024AL, AZ, AR +38 more• Siemens Medical Solutions USA, Inc.

ACUSON Maple Ultrasound (Siemens) - Software Measurement Error (2024)

Moderate

FDAAug 15, 2024AL, AZ, AR +38 more• Siemens Medical Solutions USA, Inc.

ACUSON Redwood Ultrasound (Siemens) - Software Measurement Error (2024)

Moderate

FDAAug 15, 2024AL, AZ, AR +38 more• Siemens Medical Solutions USA, Inc.

Sensis Vibe System (Siemens) – Documentation Functionality (2024)

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.

Moderate

FDAJul 3, 2024Nationwide• Siemens Medical Solutions USA, Inc

Luminos dRF Max (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

Moderate

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc

Luminos Lotus Max (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

Moderate

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc

Luminos Agile Max (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

Moderate

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc

Multitom Rax (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

Moderate

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc