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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

203

Past Year

39

Class I (Serious)

2

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 1–20 of 203 recalls

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Mo... (Siemens Medical Solutions USA, Inc) – a potential issue associated with lum... (2025)

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

FDADec 5, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAMMOMAT Inspiration (Siemens) – Incorrect Table Installation (2025)

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAMMOMAT Revelation (Siemens) – Incorrect Table Installation (2025)

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

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Moderate

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAMMOMAT Fusion (Siemens) – Incorrect Table Installation (2025)

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

Quantum Intersegmental Table (Pivotal Health) – Heat Function Risk (2025)

The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

FDAOct 9, 2025Nationwide• Pivotal Health Solutions, Inc.

MAGNETOM Cima.X Upgrade (Siemens) – ice blockage potential (2025)

There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, 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.

FDAOct 1, 2025CA• Siemens Medical Solutions USA, Inc

HARMONIC FOCUS Shears (Stryker) – continuous activation (2025)

Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

FDASep 24, 2025Nationwide• Stryker Sustainability Solutions

MAGNETOM Vida (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Spectra (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Verio (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Skyra (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

Biograph mMR (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Skyra Fit BioMatrix (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Verio Dot (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

BIOGRAPH One (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Vida Fit (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Connectom.X (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Lumina (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Skyra Fit (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Prisma (Siemens) – Magnet Venting Issue (2025)

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.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc