Canon Medical Alphenix INFX-8000F X-ray system recalled for loose ceiling movement screws
What this means
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
The agency's original wording
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1177-2026Want us to check the next one for you?
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