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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00565-1
Product Name/Description	MobileDiagnost wDR (Mobile x-ray imaging system) ARTG Number: 187112
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/05/2014
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	The MobileDiagnost wDR executes an unintended exposure under the following specific error conditions: - the hand switch is erroneously stuck in pressed position, while the system is switched off, - the system is powered up with the hand switch in that erroneous condition, - the user logs in, selects a patient for examination, gets a green ready light in, - the examination context, if the tube arm is then moved out of the zero position, the system is doing an exposure. The hazard associated to this defect is one single unintended exposure with the parameters configured previously by the user in the last examination. No continuous radiation is emitted in any case.
Recall Action	Recall for Product Correction
Recall Action Instructions	Philips plans to update the software Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. The system can be used according to the Instruction for Use without restrictions. This action has been closed-out on 10/02/2016.
Contact Information	1800 251 400 - Philips Customer Care Centre