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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00726-1
Product Name/Description	DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systems DuraDiagnost R1.0 Product Number: 712210 DuraDiagnost R2.0 and R3.0 Product Number: 712211 ARTG Number: 207424
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	1/06/2017
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	Philips has discovered via a report from the field that some welding joints on the vertical carriage brackets of the tube stand may crack. As a result, the tube arm assembly may exhibit uncharacteristic sideways movement, with the tube becoming off center. If all of the welding joints cracked, the tube arm assembly could fall down and a patient on the examination table or anyone in the vicinity could be struck by the falling tube arm assembly resulting in serious injury or death.
Recall Action	Recall for Product Correction
Recall Action Instructions	A Philips Engineer will go on-site and inspect the welding joints of the tube stand vertical carriage brackets and install the safety hooks structure, which will prevent the tube arm assembly from falling down even if all the bracket welding joints are cracked. In the interim, users are to stop using the device. This action has been closed-out on 23/03/2018.
Contact Information	1800 251 400 - Philips Customer Care Centre