Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
Alphenix INFX-8000C/B5
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Alphenix INFX-8000C/B5
- Lot codes and dates
- Serial no
- B5F2532011/UDI4987670100192
- Amount recalled
- 1 unit
Where it was sold
- Nationwide
- ID
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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