FDAMay 3, 2024device

Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356

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

The hazard

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

008848381086220088483809835000884838090040

Recall history

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

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