Canon Medical System, Usa, Inc.: Interventional Fluoroscopic X-ray System
- Recalling firm
- Canon Medical System, USA, INC.
- Product
- 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
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of ID.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a5518377-b424-463d-b50a-1b21767f97b8