Recall Z-1845-2024— Philips North America Llc

Name: FDA recall Z-1845-2024
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: K193215. Product: Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315. 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

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

Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315

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.