Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01104-1
Product Name/Description Allura Xper and Allura Clarity - software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16

Product Codes: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059, 722003, 722005, 722006, 722008, 722010, 722012, 722013, 722015, 722023.

Allura Xper FD R2.x
Product Code: 722006

Allura Xper FD R8.2.0
Product Code: 722035

ARTG Number: 175708
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/11/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue It has been discovered through customer complaints and internal testing that there is an intermittent electronic product defect. In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. No injuries attributed to the problem have been reported.
Recall Action Recall for Product Correction
Recall Action Instructions The sponsor will perform a software update to the affected devices. In the meantime, the user is advised to always observe real time dose information and cumulative fluoro time provided by the system. The fault condition is reset when a new patient case is started or when the system is restarted.
This action has been closed-out on 05/12/2016.
Contact Information 1800 251 400 - Philips Customer Care Centre