FDA Enforcement
Class II
Ongoing
AXIOM Luminos Agile
Recall: Z-1001-2023
·
Reported January 25, 2023
Enforcement
- Recall Number
- Z-1001-2023
- Event ID
- 91383
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 25, 2023
- Initiation Date
- December 9, 2022
- Classification Date
- January 19, 2023
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States
Description
AXIOM Luminos Agile
Reason
There is potential for the footrest to detach from the patient table during use.
Code Info
All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)
Distribution
Worldwide distribution
Quantity
271 units