Device product
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
Z-1000-2023
Product summary
- Event
- Event 91383
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 654 units
- Official record key
device-enforcement:Z-1000-2023
Official wording
Reason: There is potential for the footrest to detach from the patient table during use.
Code information: All serial numbers 1) AXIOM Luminos TF, Material #10093902 (no UDI) 2) AXIOM Iconos R100, Material #05895151 (no UDI) 3) AXIOM Iconos R200 C69, Material #10093961 (no UDI) 4) AXIOM Iconos R200 C20, Material #10093962 (no UDI) 5) AXIOM Luminos dRF, Material #10094200 (no UDI)
Distribution pattern: Worldwide distribution
Derived failure modes
-
Unknown
There is potential for the footrest to detach from the patient table during use.