Recall Z-2213-2025— Philips North America

Name: FDA recall Z-2213-2025
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 2 FDA 510(k) clearances: K223442, K212673. Product: MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;. 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

2 on FDA's record

K223442 — MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V.·cleared 2022-12-23
K212673 — MR 5300Philips Medical Systems Nederland B.V.·cleared 2021-11-19

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

MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

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.