FDAApril 23, 2021device
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
philips north americaphilipsphilips north
UPCs
0088483809004000884838098350
Recall history
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