Recall Z-0715-2024— Philips North America

Name: FDA recall Z-0715-2024
Creator: U.S. Food and Drug Administration
Published: 2021-07-15

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2021-07-15. It names one FDA 510(k) clearance: K213583. Product: (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359). Reason: The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.).

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2021-07-15
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K213583 — Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2022-05-16

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

(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

Reason for recall

The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)

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