Class IIDeviceOngoing

Canon Medical System, USA, INC.

Alphenix INFX-8000C/B5

Reason for recall

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

Details

Recall number: Z-0108-2027
Event ID: 99817
Recall initiated: Aug 26, 2026
Classified: Oct 7, 2026
Reported: Oct 14, 2026
Quantity: 1 unit
Distribution: US Nationwide distribution in the state of ID.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Tustin, CA, United States
Lot / code info: Serial no. B5F2532011/UDI: 4987670100192