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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00637-1
Product Name/Description Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 13/05/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue On the affected CT systems and software versions, Varian RPM drive is not mapped in CT user profile after logout/login. The Map Drive utility maps the Varian drive using full Varian credentials in the service login and then creates a script that maps it with full Varian credentials in the CT user login. Once the script has run in the CT login and the user acknowledges the drive mapped successfully, the script deletes itself. On subsequent logins, the drive will not connect because the Varian credentials are no longer available. Should this situation occur, the user will be unable to perform pulmonary gated scans.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is advising users to contact Service to login to service mode to reconnect Varian RPM drive. Philips is implementing a software upgrade as a permanent correction. This action has been closed out on 15 June 2017.
Contact Information 1800 251 400 - Philips Customer Care Centre