Philips recalls Azurion 7 imaging systems in Canada over power supply failures at start-up
Health Canada lists a Type II recall of several Azurion 7 configurations after surge voltages during start or restart can disable internal power supplies and leave systems unusable.
Health Canada has published a recall notice for certain Philips Azurion systems, made by Philips Medical Systems Nederland B.V. The recall date is 23 October 2026, and the notice was posted on 29 October 2026 under identification number RA-82876.
According to the notice, the issue lies in the power distribution unit, an internal assembly containing several power supplies. Philips found that in some systems one or more of these supplies can fail because of energy peaks, known as surge voltages, when the system is started or restarted.
If a power supply fails in this way, the unit does not deliver the direct current power that essential system components need. The system then cannot complete its start or restart, imaging functionality is unavailable, and the system cannot be used clinically.
The listed products are Azurion 7 M20, M12, B12 and B20 configurations, with model or catalogue numbers 722 224, 722 079, 722 067, 722 223, 722 078, 722 226 and 722 068. Lot or serial numbers are given as not applicable. Health Canada classifies the recall as Type II and directs healthcare audiences to contact the manufacturer for further information. As general context, a Type II recall generally concerns products that may cause temporary or medically reversible health effects, or where serious harm is unlikely.
What it means for your team
- Device safety and quality teams at Canadian sites with Azurion 7 systems should check installed units against the seven listed model numbers.
- Because no serial or lot ranges are given, identification rests on model or catalogue number, so confirmation with Philips may be needed.
- Clinical engineering and operations teams may wish to review contingency arrangements for imaging unavailability, as the notice says affected systems stay unusable after a failed start.
- Regulatory teams in other markets may want to check whether equivalent field actions apply, since this notice covers Canada only.
Official source: Health Canada ↗
Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.