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Health Canada Medical devices

Ingenia Ambition X

Issued October 18, 2023
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
Hazard description
Performance
Product
Product name
Ingenia Ambition X
Reference
ID
RA-74434