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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