ALLURA XPER and AZURION 7
Standard priority
What you should do
- 1The actions that should be taken by the user in order to prevent risks for patients or users•Ensure that the wired foot switch is always connected to the system.
- 2The wired footswitch is always provided with the AlluraXper and the Azurion systems.•Immediately start using the wired foot switch in case the wireless foot switch loses connection.•Circulate this notice to all users of this device so that they are aware of the issue.•Place this Urgent Medical Device Recall Letter with the documentation of the Philips AlluraXper or Azurion system.•Return the attached Urgent Medical Device Recall Letter Response Form to Philips to confirm that:o the Allura Xper and Azurion system wired foot switch is connected to the systemo the users of the system have reviewed and understood this Urgent Medical Device Recall Letter.
The issue
Software defect
Affected product
ALLURA XPER and AZURION 7
Where it was sold
Canada (national)Reported in the official notice — confirm there.
Issued by
Health Canada — Medical devices
Read the official Government of Canada notice
All recallsRecallGuardian ranks, illustrates and rewrites recalls in plain language. The official notice is authoritative — confirm model numbers, lot codes, dates and remedies there.