Z-1000-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2023
- Initiation Date
- December 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 654 units
Product Description
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
Reason for Recall
There is potential for the footrest to detach from the patient table during use.
Distribution Pattern
Worldwide distribution
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)