Siemens MAGNETOM Verio Dot MRI Systems Recalled for Helium Leak Risk

Plain-English summary

Siemens Medical Solutions USA, Inc is recalling 59 MAGNETOM Verio Dot MRI systems (Model 10684333) distributed worldwide, including throughout the United States.

A potential ice blockage may form or currently exist within the magnet venting system. If a quench occurs, helium gas may be unable to escape through the normal venting paths because of the blockage. This prevents helium from being released as designed, leading to pressure buildup within the helium containment system.

The accumulated pressure could rupture the helium containment system, potentially resulting in a helium leak into the scanning room. No illnesses or injuries related to this potential hazard have been reported.

Hospitals and imaging centers with affected MAGNETOM Verio Dot systems should contact Siemens Medical Solutions USA, Inc for service guidance and remediation options. The FDA recall notice (Z-2665-2025) provides specific model numbers, serial numbers, and UDI codes to identify affected devices.

The recalled product

Product

MAGNETOM Verio Dot. Model Number: 10684333.

Manufacturer

Siemens Medical Solutions USA, Inc

Category

Medical Device — MRI System

Hazard

• ice-blockage
• pressure-buildup
• helium-leak
• system-rupture

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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