Health product recall

ALLURA XPER FD10 and FD20/10 (PRODUCT OF ALLURACLARITY FAMILY)

Last updated

Summary

Product
ALLURA XPER FD10 and FD20/10 (PRODUCT OF ALLURACLARITY FAMILY)
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information

Affected products

Affected Products

Lot or serial number

Model or catalog number

ALLURA XPER FD10

Not applicable

001443
ALLURA XPER FD10

ALLURA XPER FD20/10 (PRODUCT OF ALLURACLARITY FAMILY)

Not applicable

722029

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 start date: 2021-10-25

Additional information

Details
Original published date: 2021-11-26
Alert / recall type
Health product recall
Category
Health product - Medical device - Radiology
Companies

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V

VEENPLUIS 6, BEST

Netherlands, 5684 PC

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63647