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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01224-1
Product Name/Description	DigitalDiagnost (Digital diagnostic X-Ray System). All systems with Eleva software version 3.0.x ARTG Number: 117662
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/12/2012
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	Philips previously notified owners of DigitalDiagnost systems with software releases 3.0.1 and 3.0.2, that a new software release 3.0.3 would be installed on their systems (without due consultation with the TGA). However, software release 3.0.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side of an image is rotated. Software release 3.0.4 corrects this defect in release 3.0.3, and it will be installed on affected systems in place of release 3.0.3. When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
Recall Action	Recall for Product Correction
Recall Action Instructions	Update to system software
Contact Information	1800 251 400 - Philips Customer Care Centre