Canon Medical Alphenix INFX-8000C/B5
The Alphenix INFX-8000C/B5 has bolts that may loosen, causing the tabletop to shift and misalignment.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Canon Medical System, USA, INC. recalled the Alphenix INFX-8000C/B5 after the FDA noted that loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in positional, imaging, and patient misalignment and a longitudinal motion error. The recall of one unit began on August 26, 2026, and was added to the FDA's Enforcement Report on October 7, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
Alphenix INFX-8000C/B5
- UDI-DI
- 4987670100192
Details
- Company began the recall
- Event ID
- 99817
- Company
- Canon Medical System, USA, INC.
- Hazard
- Device defect
- Quantity recalled
- 1 unit
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
