AXIOM Luminos Agile
- Recall Initiated
- December 9, 2022
- Posted
- January 20, 2023
- Recall Number
- Z-1001-2023
- Quantity
- 271 units
- Firm Location
- Malvern, PA
Reason for Recall
There is potential for the footrest to detach from the patient table during use.
Distribution
Worldwide distribution
Lot / Code Info
All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)
Root Cause
Process control
Action Taken
A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructions for Use for each reported system.