MRI Scanner Helium Venting System Ice Blockage and Rupture Risk

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 39 units of the MAGNETOM Skyra Fit BioMatrix MRI system (Model 11516217). These are advanced medical imaging devices installed in healthcare facilities for conducting diagnostic magnetic resonance imaging.

The recall addresses a potential safety hazard: ice blockage may form within the magnet's helium venting system. During a quench event (emergency helium release), ice blocking the venting path could prevent helium gas from escaping, causing pressure to build up inside the helium containment system. If pressure becomes excessive, the containment could rupture, allowing helium to leak into the scanning room and potentially creating hazardous conditions for patients and staff.

The 39 affected units have been distributed worldwide to the United States and numerous countries globally. The specific serial numbers and UDI codes for affected units are documented in the official FDA recall notice.

This Class I recall is the FDA's most serious classification. Healthcare facilities should verify whether any of their MRI systems match the recalled serial numbers or UDI codes and review the FDA's recall notice for detailed identification and guidance.

The recalled product

Product

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Manufacturer

Siemens Medical Solutions USA, Inc

Category

Medical Device — MRI Imaging System

Hazard

• ice-blockage
• pressure-buildup
• rupture
• 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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