FDAAugust 28, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for an ice blockage to form or currently 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. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

What to do

FDA enforcement status: Ongoing

Brands named

siemens medical solutionssiemenssiemens medical

UPCs

04056869039176

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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