MAGNETOM Lumina MRI systems recalled over helium venting ice blockage risk

Plain-English summary

MAGNETOM Lumina (DE) MRI systems, model number 11344916, are being recalled because an ice blockage may form, or may already exist, within the magnet venting system.

In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. That pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

The recall covers 130 units, distributed worldwide including nationwide in the United States. The FDA has classified the recall as Class I.

Operating sites should follow the manufacturer's instructions for inspection and correction of the venting system before further use.

The recalled product

Product

MAGNETOM Lumina (DE). Model Number: 11344916.

Manufacturer

Siemens Medical Solutions USA, Inc

Category

Medical Device — MRI system

Hazard

• helium-leak
• pressure-buildup
• venting-failure
• quench

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.

Related recalls