FDAApril 23, 2021device

Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

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

The hazard

The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

00884838090057

Recall history

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

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