Device product
AXIOM Luminos Agile
Z-1001-2023
Product summary
- Event
- Event 91383
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 271 units
- Official record key
device-enforcement:Z-1001-2023
Official wording
Reason: There is potential for the footrest to detach from the patient table during use.
Code information: All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)
Distribution pattern: Worldwide distribution
Derived failure modes
-
Unknown
There is potential for the footrest to detach from the patient table during use.