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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00135-1
Product Name/Description ProGrade Rel.1x Systems

Product Code: MQB

Model Number: 71209

ARTG Number: 228352
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 12/02/2018
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue If the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system. The image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. To continue, the operator can reset the SkyPlate detector by removing its batteries, but the acquired image is lost and a re-take is necessary.
Recall Action Product Defect Correction
Recall Action Instructions Philips plans to release a new HP firmware to the installed base.
In addition the existing Access Point Hardware in the field needs to be patched.
A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented.

This action has been closed out on 11/07/2019
Contact Information 1800 251 400 - Philips Customer Care Centre