Alphenix INFX-8000C/B5 Recall
Alphenix INFX-8000C/B5
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Alphenix INFX-8000C/B5 recalled?
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 should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
Serial no. B5F2532011/UDI: 4987670100192
- Agency record number
- Z-0108-2027
- Product
- Alphenix INFX-8000C/B5
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of ID.
- Recall started
- August 26, 2026
- Report date
- October 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)