Recall Z-1804-2025— Philips North America Llc

Name: FDA recall Z-1804-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-13

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2025-05-13. It names 2 FDA 510(k) clearances: K223442, K212673. Product: Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;. Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2025-05-13
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

Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;

Reason for recall

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

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