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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00122-1
Product Name/Description Allura Xper R7.2.x (Fluoroscopic diagnostic x-ray system)

Product codes: 722003, 722005, 722006, 722008, 722014, 722015 with system software release 7.2.x

ARTG Number:175708
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/02/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required. No injuries attributed to the problem are reported.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare is advising the user to always observe realtime 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. Philips Healthcare service engineers will install software release R7.2.8 which addresses the buzzer issue. This action has been closed-out on 3/8/2016.
Contact Information 1800 251 400 - Philips Customer Care Centre