TemporaryFDAOngoing
Can cause harm that is usually temporary.
Alphenix INFX-8000C/B5
Check the device or its packaging for
Serial no. B5F2532011/UDI: 4987670100192
- Why
- Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
- Distributed
- US Nationwide distribution in the state of ID.
- Company
- Canon Medical System, USA, INC.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0108-2027 · retrieved 7 October 2026
Read the official notice