Recall Z-1950-2024— Philips North America Llc

Name: FDA recall Z-1950-2024
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: K213583. Product: HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732. Reason: Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard.

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

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

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

Reason for recall

Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard

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