FDA-Device2026-10-14Class IIPROCESSING DEFECT
Canon Medical Alphenix INFX-8000C/B5 recalled for loose bolts causing tabletop misalignment
What this means
Bolts that secure the longitudinal movement mechanism on the Canon Medical Alphenix INFX-8000C/B5 imaging system may loosen over time. This can cause the patient tabletop to shift unexpectedly, leading to misalignment during imaging procedures and motion errors.
- If your facility operates an Alphenix INFX-8000C/B5 (serial B5F2532011), contact Canon Medical System, USA, INC. immediately for inspection and repair instructions.
- Do not use the affected system until bolts have been inspected and secured.
The agency's original wording
Hazard
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
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of ID.
Affected count
1 unit
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Alphenix INFX-8000C/B5
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2027More Canon recalls
- FDA-Device2026-09-02Canon Medical Alphenix X-ray systems recalled for loose ceiling arm screws
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