Canon Medical Alphenix INFX-8000C X-ray system recalled for loose ceiling screws
What this means
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
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-1176-2026Want us to check the next one for you?
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