Recall Z-0810-2024— Philips North America

Name: FDA recall Z-0810-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-29

Class III · Ongoing

Class III FDA medical device recall by Philips North America, initiated 2023-12-29. It names one FDA 510(k) clearance: K193215. Product: Ingenia Ambition X, Model No. 782109. Reason: An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel..

Recalling firm: Philips North America
Classification: Class III
Status: Ongoing
Initiated: 2023-12-29
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 Ambition X, Model No. 782109

Reason for recall

An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

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