Siemens Medical Solutions USA, Inc Recalls

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

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Recall Summary

Total Recalls

747

Past Year

45

Class I (Serious)

10

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 747 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.

Moderate

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

The Pressio 2 ICP Monitoring System, Model Number PSO-400... (Sophysa Rue Sophie Germain Besancon France) – customer complaints of pressio monito... (2025)

Customer complaints of Pressio monitor rebooting.

FDANov 17, 2025Nationwide• Sophysa Rue Sophie Germain Besancon France

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.

FDAOct 24, 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 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

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

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 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

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 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

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 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 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 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

MAGNETOM Cima.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 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

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 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 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

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Siemens Medical Solutions USA, Inc Recalls

Recall Summary

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

The Pressio 2 ICP Monitoring System, Model Number PSO-400... (Sophysa Rue Sophie Germain Besancon France) – customer complaints of pressio monito... (2025)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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