MAGNETOM Vida MRI systems recalled over ice blockage in magnet venting

Plain-English summary

MAGNETOM Vida (DE) MRI systems, model number 11060815, 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 498 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 Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

Manufacturer

Siemens Medical Solutions USA, Inc

Category

Medical Device — MRI system

Hazard

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

Affected units

498

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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