Health product recall

Ingenia Ambition X

Last updated

Summary

Product
Ingenia Ambition X
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected Products

Lot or serial number

Model or catalog number

Ingenia Ambition X

Not applicable.

782109
781356

Issue

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.  The initial design of the hoisting blocks on top of the magnet did not meet the required mechanical specification. The diameter to meet the required bolt‐on interface surface for the swivel eye bolts, used as lifting hardware, was too small. A hazardous situation could occur, only when the magnet is lifted by crane, via attachments to these lifting blocks. Large angles between the individual slings connected to the lifting blocks of the magnet can result in increased stresses in these blocks. When the lifting interface would fail, a person beneath of near the magnet that is hoisted could be hit. No incidents have been reported.

Recall Start Date: October 3, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74434

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