ALLURA XPER and AZURION 7
Reason for Recall / Hazard
Software defect
Product Description & Identification
The 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. The 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.
Affected Products
ALLURA XPER and AZURION 7
Additional Source Details
| Field | Value |
|---|---|
| N I D | 63591 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/allura-xper-and-azurion-7 |
| Issue | Software defect |
| Title | ALLURA XPER and AZURION 7 |
| Product | ALLURA XPER and AZURION 7 |
| Archived | 0 |
| Category | Radiology |
| Last updated | 2021-11-12 |
| Organization | Medical devices |
| Recall class | Type II |
| What you should do | The 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. The 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. |