Philips Azurion software defects prompt Class II recall in Canada

Philips Medical Systems Nederland B.V. is recalling the Azurion 7 M20 (model 722234) in Canada, according to a Health Canada notice posted on 13 November under reference RA-82951. The recall is dated 6 November 2026 and is classed as Class II. The notice says nothing about financial impact, the number of systems affected, or whether Philips will offer a software update or other remedy.

The notice concerns two defects in systems running Azurion R3.1 software, either of which can interrupt X-ray imaging, motorised movement, or both. The first involves the component that verifies installed licences and switches on optional features. It reportedly adds to the size of the Windows registry database each time the system starts or restarts. Once the registry outgrows what the component can load, the component no longer starts, and the system cycles through restarts without completing startup. The screen stays on a message saying the X-ray system is booting.

The second defect applies only to systems fitted with the Poly-G3 frontal stand. When the stand is told to travel along its length, the system can register a gap between expected and measured positions, which Health Canada ties to an erratic reading from the position-sensing potentiometer. The system then cuts motion power to the stand and displays a message that some stand movements are unavailable. Imaging and table movement carry on, and a cold restart or a geometry restart clears the condition, the notice says.

Health Canada tells users to contact the manufacturer for more information. The entry lists no lot or serial numbers and reports no injuries. As context, Canadian regulators generally apply the Class II label to products that may cause temporary or medically reversible health effects, where serious harm is considered unlikely. The entry also says nothing about regions outside Canada.