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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00424-1
Product Name/Description DuraDiagnost 3.0/4.0 X-ray system

Product numbers 712211, 712214

Multiple lot numbers

ARTG Number: 207424
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 18/05/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The system is designed to emit an acoustic signal (beep) upon termination of an exposure. However, if the system has been powered on for more than 12 hours, the system will no longer emit this signal.
Recall Action Recall for Product Correction
Recall Action Instructions Philips recommends that the system is rebooted at least every 11 hours until the software is upgraded. A Philips service engineer will contact the customers to implement the software upgrade to release 02.3400.015. This action has been closed-out on 17/08/2016.
Contact Information 1800 251 400 - Philips Customer Care Centre