Recall Z-0108-2027
- Recall number
- Z-0108-2027
- Event number
- 99817
- Firm
- Canon Medical System, USA, INC.
- Firm FEI
- 2020563
- Product code
- OWB
- Status
- Open, Classified
- Initiated
- 2026-08-26
- Posted
- 2026-10-07
- Root cause
- Process control
- 510(k) numbers
- K210900, K254205, K172574, K212523, K123529, K250010, K183109, K120073, K212557, K230949, K061163, K181834, K140041, K123226, K181804, K223410, K041605, K070834, K974355, K062647, K133819, K022069, K173639, K190768, K142740, K203551, K221335, K230185, K233230, K250282
Product#
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