FDA-Device2026-02-04Class IIPROCESSING DEFECT

Canon Medical Alphenix INFX-8000V X-ray system recalled for loose ceiling screws

OTHERNationwide distribution

Check your Canon Medical X-ray system

Fixing screws on the ceiling movement gear of Canon Medical Alphenix INFX-8000V interventional X-ray systems may loosen over time. This can prevent the ceiling arm from moving side-to-side, cause unusual noises from the suspension system, or trigger sensor errors on the equipment.

  • If you operate one of the affected serial numbers listed in the recall, contact Canon Medical immediately for inspection and repair
  • Do not ignore abnormal noises or sensor errors from the ceiling suspension system
  • Ensure ceiling lateral movement is tested before clinical use
Hazard

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

Sold states
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Affected count
332 units
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Alphenix INFX-8000V, interventional fluoroscopic x-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1179-2026

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