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Philips recalls Azurion 7 M20 over software faults that can halt imaging or stand movement

🇨🇦 Health Canada · Fri 13 Nov 2026

Health Canada lists a Class II recall of Philips Azurion R3.1 systems after two software issues were found, one causing a reboot loop and one cutting motion power.

Health Canada has published a Class II recall of the Philips Azurion 7 M20 (model 722234), made by Philips Medical Systems Nederland B.V. The recall date is 6 November 2026 and the notice was posted on 13 November under identification number RA-82951.

Philips has found two software issues in Azurion R3.1 systems that may cause loss of X-ray imaging, loss of motorised movement, or both. The first concerns the License Manager, which checks installed licences and enables optional functions. According to the notice, it enlarges the Windows registry database at every start or restart.

Over time the registry can exceed the maximum size the License Manager is able to load. The License Manager then fails to start and the system enters a continuous reboot loop. Booting never finishes, and the screen keeps showing the message "X-ray system is booting...".

The second issue affects only Azurion systems fitted with the Poly-G3 frontal stand. When the stand is asked to move longitudinally, the system may detect a mismatch between the expected and measured positions. Health Canada attributes this to a glitch in the value supplied by the position-sensing potentiometer.

On detecting the mismatch, the system automatically cuts motion power to the frontal stand and displays "Some stand movements are not available". X-ray imaging and table movements keep working. A cold restart of the system or a restart of the geometry resolves the situation, the notice says.

The notice tells healthcare users to contact the manufacturer for further information. It gives no lot or serial numbers, and it does not describe a corrective software release or report any injuries. In Canada, a Type II recall generally covers products that may cause temporary or medically reversible health effects, where serious harm is unlikely.

What it means for your team

  • Quality and field-safety teams at sites with Azurion R3.1 systems should check whether their units fall under model 722234 and contact Philips for details on remediation.
  • The reboot-loop failure develops over time as the registry grows, so it is a potential availability risk for imaging suites. Sites may wish to review contingency plans for system downtime.
  • The stand-movement fault applies only to Poly-G3 frontal stand configurations and is recoverable by a restart, with imaging and table movement unaffected.
  • Regulatory teams should track RA-82951 and look for any equivalent field safety notices in other markets, since the Health Canada entry gives no information about regions beyond Canada.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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