Recall Z-2215-2025— Philips North America

Name: FDA recall Z-2215-2025
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 3.0T Model Number (REF): 782145;. 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 3.0T Model Number (REF): 782145;

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.