Recall Z-1854-2024— Philips North America Llc

Name: FDA recall Z-1854-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-03

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2024-05-03. It names one FDA 510(k) clearance: K212673. Product: MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110. Reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-05-03
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 (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110

Reason for recall

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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