Siemens MAGNETOM Lumina MRI system: potential helium venting system blockage

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the MAGNETOM Lumina (DE) MRI system, Model Number 11344916. Approximately 130 units of this diagnostic imaging device were distributed worldwide, including throughout the United States and over 80 countries.

The recall addresses a potential hazard where ice may form or already exist within the magnet's helium venting system. During a magnet quench event, a blockage could prevent pressurized helium gas from escaping through designed venting paths, leading to pressure buildup within the helium containment system. This accumulating pressure could ultimately rupture the helium containment, potentially releasing helium gas into the scanning room.

The recall affects all affected MAGNETOM Lumina units worldwide, identified by model number 11344916. Healthcare facilities and medical imaging centers operating these systems should contact Siemens Medical Solutions USA, Inc. for information about available remediation or replacement options. No illnesses or injuries have been reported to date.

The recalled product

Product

MAGNETOM Lumina (DE). Model Number: 11344916.

Manufacturer

Siemens Medical Solutions USA, Inc

Category

Medical Device — Diagnostic Imaging

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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