Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Recall
- Recall Number
- Z-1795-2021
- Event Number
- 87962
- Firm
- Philips North America Llc
- FEI Number
- 3016618143
- Product Code
- LNH
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- April 23, 2021
- Posted
- June 4, 2021
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289
Description
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
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.
On March 23, 2021, Philips issued an Urgent Medical Device Correction notice to customers via letter stating Philips identified an issue with specified MR systems. 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. In the initial design of the hoisting blocks, the diameter to meet the required bolt-on interface surface for the swivel eye bolts, used as lifting hardware, did not meet the required specification. HOW TO IDENTIFY AFFECTED PRODUCTS Ingenia Ambition X (781356) and Ingenia Ambition S (781359) ACTION TO BE TAKEN BY CUSTOMER / USER No action is required by the customer, as the clinical use of the MR system is not affected. In case of a planned decommissioning or movement of the magnet, and this FCO is not installed yet, please contact your local Philips representative. ACTIONS PLANNED BY PHILIPS Via FCO781 00524 a mechanical solution will be rolled out to the affected MR systems. ***Updated November 2023*** Additional customers were identified and notified on August 22, 2023.
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156 MR Systems