Device recall
Alphenix INFX-8000C/B5
- Recall number
- Z-0108-2027
- Event id
- 99817
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Canon Medical System, USA, INC.
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 26, 2026
- Center classification date
- Oct 7, 2026
- Product code
- OWB
- Device type
- Interventional Fluoroscopic X-Ray System
- Reason
- 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
- Root cause
- Process control
- Quantity
- 1 unit
- Code info
- Serial no. B5F2532011/UDI: 4987670100192
- Distribution
- US Nationwide distribution in the state of ID.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K210900
- Location
- Tustin, CA, United States