FDAJune 12, 2023device

Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

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

The hazard

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

0088483808810800884838098329

Recall history

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

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