Alphenix INFX-8000C/B5 recall (Canon Medical System, USA, INC.)
Medical deviceClass IIOngoing
Summary: Canon Medical System, USA, INC. is recalling Alphenix INFX-8000C/B5. 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.
What is being recalled
Alphenix INFX-8000C/B5
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
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of ID.
How to tell if yours is affected
Serial no. B5F2532011/UDI: 4987670100192
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0108-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 26, 2026 |
| Reported | October 14, 2026 |
| Company | Canon Medical System, USA, INC. |
| Company location | Tustin, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1 unit |
More recalls from Canon Medical System, USA, INC. · all medical device recalls · recalls from August 2026