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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00831-1
Product Name/Description Allura Xper FD
(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)

Allura Xper FD with product codes: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059.

ARTG: 175708
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 28/08/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips Healthcare has discovered through customer complaints and internal testing 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, as is required in 21CFR1020.32 (h)(2)(ii) and IEC 60601-2-54, clause
Recall Action Recall for Product Correction
Recall Action Instructions A mandatory Field Change Order (FCO) with reference FCO72200285 is being released that requires Philips field service engineers to install Software release R8.2.16 which addresses the buzzer issue. This action has been closed-out on 12/05/2017.
Contact Information 1800 251 400 - Philips Customer Care Centre