Recall Z-1796-2021— Philips North America Llc

Name: FDA recall Z-1796-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-23

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2021-04-23. It names one FDA 510(k) clearance: K181479. Product: Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.. Reason: The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2021-04-23
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K181479 — Ingenia Ambition S and Ingenia Ambition XPhilips Medical Systems Nederland B.V.·cleared 2018-08-03

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 S - Model Number: 781359 Diagnostic MR system.

Reason for recall

The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

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