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FDAJuly 15, 2021device

(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

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

The hazard

The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

0088483809004000884838090057

Recall history

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

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(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359) — Recall Details · AllClear