MAGNETOM Vida Fit MRI systems recalled over magnet vent ice blockage

Plain-English summary

MAGNETOM Vida Fit MRI systems, model number 11410481, 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 41 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.

The recalled product

Product

MAGNETOM Vida Fit. Model Number: 11410481.

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.

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