Siemens MRI Helium Containment Rupture Risk from Vent Blockage

Plain-English summary

This recall affects 56 Siemens MAGNETOM Skyra fit MRI systems (Model 10849580) distributed worldwide. These systems may have ice blockage within the magnet venting system.

In the event of a quench, helium gas may be unable to escape through the designed venting paths. This could lead to pressure build-up within the helium containment system.

The pressure build-up could rupture the helium containment system, potentially resulting in a helium leak into the scanning room. While no injuries or incidents have been reported, the FDA has classified this as a Class I recall due to the serious potential hazard.

Affected healthcare facilities should immediately contact Siemens Medical Solutions USA, Inc. for guidance on remediation. Affected units can be identified using the UDI and serial numbers listed in the official FDA recall notice.

The recalled product

Product

MAGNETOM Skyra fit. Model Number: 10849580.

Manufacturer

Siemens Medical Solutions USA, Inc

Category

Medical Device — Diagnostic Imaging / MRI

Hazard

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

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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