Siemens MAGNETOM Prisma MRI Systems Recalled for Potential Helium Containment Rupture

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the MAGNETOM Prisma magnetic resonance imaging (MRI) system (Model 10849582) worldwide. Approximately 101 units have been distributed globally.

The recall addresses a potential hazard in the magnet venting system: ice blockages may form or currently exist within the helium venting pathways. During a quench event, such a blockage could prevent helium gas from escaping through the designed venting paths. The inability to vent would cause pressure to build up inside the helium containment system.

If pressure builds up unchecked, the helium containment system could rupture, potentially releasing helium into the scanning room. Healthcare facilities using affected units should contact Siemens for additional information and guidance.

This recall is classified as an FDA Class I, indicating the potential for serious harm.

The recalled product

Product

MAGNETOM Prisma. Model Number: 10849582.

Manufacturer

Siemens Medical Solutions USA, Inc

Category

Medical Device — Magnetic Resonance Imaging (MRI) Equipment

Hazard

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