Recall Z-2201-2025— Philips North America

Name: FDA recall Z-2201-2025
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. It names one FDA 510(k) clearance: K193215. Product: Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;. 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

510(k) clearances named in this recall

1 on FDA's record

K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2020-04-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

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.