FDA-Device2026-02-04Class IIPROCESSING DEFECT

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

OTHERNationwide distribution

Check your Canon Medical X-ray system

Fixing screws in the ceiling-mounted arm of Canon Medical's Alphenix INFX-8000C interventional X-ray systems may become loose. This can cause the ceiling arm to stop moving sideways, create unusual noises, or trigger sensor errors during use.

  • If you operate this equipment, contact Canon Medical System USA immediately with your system's serial number
  • Do not use the ceiling lateral movement feature until the screw issue is inspected and corrected
  • Check the affected serial numbers list to confirm whether your unit is involved
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
172 units
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Alphenix INFX-8000C, interventional fluoroscopic x-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1176-2026

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