Recall Z-2216-2025— Philips North America

Name: FDA recall Z-2216-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-30

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2025-06-30. FDA's recall record names no specific 510(k) clearance for this event. Product: SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;. Reason: 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..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2025-06-30
Firm location: Cambridge, MA, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.