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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01208-1
Product Name/Description DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1

All products with software release 2.0.2 and 2.0.2SP1

ARTG Number: 117662
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/12/2012
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips previously notified owners of affected DigitalDiagnost systems that software release 2.1.3 would be installed on the systems to modify the
appearance of a mirror icon. However, software release 2.1.3 contained a defect that may result in the incorrect placement of the
electronic marker (left/right) indicating the patient side if an image is rotated.

Software release 2.1.4 addresses both the original & new issue, & it will be installed on affected systems in place of release 2.1.3. If software release
2.1.3 has already been installed on a system, it will be replaced with release 2.1.4.

With DigitalDiagnost R 2.0.2 a mirrored “R in a circle” is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is
mirrored back inside the PACS system, an unmirrored “R in a circle” appears in the lower left corner. This can be mistaken for a “right patient side” marker,
although this can appear on the left patient side.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare will be installing a software update to address the identified issue.
Contact Information 1800 251 400 - Philips Customer Care Centre