Canon Medical Systems Recalls Alphenix Systems Due to Software Error

Product & Food Recalls medium Health Canada · · Canada

Canon Medical Systems Corporation has issued a recall for Alphenix INFX-8000c and INFX-8000v units due to a software defect that causes internal errors during clinical analysis.

What Happened

Canon Medical Systems Corporation has identified a software issue affecting certain Alphenix medical imaging systems. According to the manufacturer, an internal error occurs if a user attempts to perform an “F-STORE” or image acquisition while the CAAS clinical analysis function is active. The company confirmed the error is rooted in the system software.

Which Products Are Affected

The recall affects the following Alphenix Main Units and specific serial numbers:

  • Alphenix INFX-8000c-Main Unit (Model INFX-8000C/PF): S/N PFD2492006
  • Alphenix INFX-8000c-Main Unit (Model INFX-8000C/QW): S/Ns QWB2472001, QWB2512002, QWB2567001
  • Alphenix INFX-8000c-Main Unit (Model INFX-8000C/QE): S/N QEA2512001
  • Alphenix INFX-8000c-Main Unit (Model INFX-8000C/QU): S/Ns QUB2482003, QUB2492004, QUB2472002, QUB2557003, QUB2512005
  • Alphenix INFX-8000v-Main Unit (Model INFX-8000V/Q1): S/N Q1B2472001

What You Should Do

To avoid the internal error, operators must terminate the CAAS clinical analysis function before performing F-STORE or image acquisition. Users should follow any further instructions provided by Canon Medical Systems Corporation regarding software updates or technical corrections.

Why This Matters

This software malfunction can cause system errors during medical procedures, potentially interrupting clinical workflows and image acquisition in a healthcare setting.

Source

For more information, visit the official Health Canada recall notice.

Source: Health Canada Official Notice