Recall Z-0973-2024— Philips North America

Name: FDA recall Z-0973-2024
Creator: U.S. Food and Drug Administration
Published: 2022-01-06

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2022-01-06. It names one FDA 510(k) clearance: K153324. Product: Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system. Reason: Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2022-01-06
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K153324 — Ingenia 1.5T and Ingenia 1.5T S R5.2Philips Medical Systems Nederlands B.V.·cleared 2016-03-22

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 (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Reason for recall

Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

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