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FDAJune 30, 2025device

SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

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

The hazard

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

008848380950830088483809890900884838105805

Recall history

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

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SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129; — Recall Details · AllClear