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Health Canada Medical devices

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

Issued November 25, 2021
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
Hazard description
Software defect
Product
Product name
ALLURA XPER FD10 and FD20/10 (PRODUCT OF ALLURACLARITY FAMILY)
Reference
ID
RA-63647