Health product recall

ALLURA XPER and AZURION 7

Last updated

Summary

Product
ALLURA XPER and AZURION 7
Issue
Medical devices - Software defect
What to 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 system
o the users of the system have reviewed and understood this Urgent Medical Device Recall Letter.

Affected products

Affected Products Lot or serial number Model or catalog number
ALLURA XPER FD10 (PRODUCT OF ALLURACLARITY FAMILY) Not applicable. 722026
ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY) Not applicable. 722028
AZURION 7 M12 Not applicable. 722 078 722 223
AZURION 7 M20 Not applicable. 722 079 722 224
AZURION 7 B12 Not applicable. 722 067
AZURION 7 B20 Not applicable. 722 068

Issue

A problem has been identified in the Philips Allura XPER and Azurion systems that could pose a risk for patients. Philips has discovered that the wireless foot switch can suddenly stop responding due to a firmware bug when a number of ambient conditions coexist, such as EMC disturbance and the presence of other wireless devices in the room. The wireless footswitch is an option to philips allura  XPER and Azurion systems to release live Fluoroscopy and exposure. Recovery of this error can be done by means of a cold restart of the system [power down, power up], which restores the functionality of the base station.

 

Recall date: 2021-10-25

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 system
o the users of the system have reviewed and understood this Urgent Medical Device Recall Letter.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V

VEENPLUIS 6, BEST

NETHERLANDS

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63591