FDAJune 12, 2023device

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)

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

008848380881150088483809833600884838099746

Recall history

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

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