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

The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

0088483808811500884838098336008848380997460088483810412900884838108608

Recall history

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

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