FDA-Device2026-02-04Class IIPROCESSING DEFECT

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

OTHERNationwide distribution

Contact Canon Medical about your Alphenix X-ray system

Fixing screws on the ceiling movement gear in Canon Medical's Alphenix INFX-8000F X-ray systems may become loose over time. This can prevent the ceiling arm from moving side to side, cause unusual noises, or trigger sensor errors during procedures.

  • If your facility operates an affected system (check your serial number against the recall list), contact Canon Medical immediately for instructions
  • Do not continue using the system if you notice ceiling movement problems, abnormal noise, or sensor errors
  • Ask Canon Medical about inspection or repair options
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
98 units
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Alphenix INFX-8000F, interventional fluoroscopic x-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1177-2026

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