Canon Medical Alphenix INFX-8000H X-ray system recalled for loose ceiling suspension screws
What this means
Fixing screws on the ceiling-mounted arm of certain Canon Medical Alphenix X-ray systems may become loose. This can prevent the arm from moving side to side, cause unusual noise, or trigger error messages. Three units worldwide are affected.
- If you operate an Alphenix INFX-8000H system, check its serial number against the affected list: D2A1672385, A2A20Z2165, B2A1692426
- Contact Canon Medical System, USA, Inc. immediately if your system's serial number matches
- Do not operate the system if you notice abnormal noise or movement limitations until screws are inspected and tightened
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-1178-2026Want us to check the next one for you?
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