Recall Z-1587-2024— Philips North America Llc

Name: FDA recall Z-1587-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-12

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2024-03-12. It names one FDA 510(k) clearance: K212673. Product: MR 5300, Magnetic Resonance System.. Reason: Patient support table floor plate may be incorrectly installed..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-03-12
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

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, Magnetic Resonance System.

Reason for recall

Patient support table floor plate may be incorrectly installed.

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