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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00736-1
Product Name/Description DigitalDiagnost, Release 4.1/4.1.1
(Digital diagnostic X-Ray system)

ARTG Number: 117662
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/08/2015
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. If this occurs, the system operator may be unsure that the exposure was correctly obtained, which may result in the decision to repeat an exposure.
Recall Action Recall for Product Correction
Recall Action Instructions Philips plans to install a software upgrade (i.e., Release 4.1.2) in affected systems, which will eliminate this issue. A Philips Service Engineer will contact affected customers when the Field Action Kit is available to be implemented. Until the system software is upgraded to release 4.1.2 to eliminate the potential loss of the acoustic signal upon termination of an exposure, Philips recommends that the system is rebooted at least every 11 hours. This action has been closed-out on 22/08/2016.
Contact Information 1800 251 400 - Philips Customer Care Centre