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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01387-1
Product Name/Description	Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6 ARTG Number: 98868
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/11/2017
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	Philips have identified multiple issues with the Philips Brilliance 64 / Ingenuity Family running software version 4.1.6 Issue 1: Cardiac Signal not found in Workflow Issue Issue 2: Scan may start at the top of the head, which may not be where the operator is expecting the scan to start Issue 3: Pulmo Gates on Cardiac Workflow Issue Issue 4: In the Plan viewer if the start position is modified the total length of the acquisition will changes as well. Issue 5: Image volumes are not found in patient directory when thin images are included in one of the multiple results Issue 6: Application may fail when modifying the results Plan Box during 3D Calcium Score Issue 7: Tube too hot Issue 8: Memory overflow Issue Issue 9: While the reconstruction is in progress disconnecting the Recon box (CIRS) may not give error message Issue 10: Issue with the Generator Monitor state machine in RHost code Issue There have been no injuries reported as a result of these issues.
Recall Action	Recall for Product Correction
Recall Action Instructions	Philips is providing users with work around instructions to follow as an interim measure. Philips will be performing a software update as a permanent correction. This action has been closed out on 12/02/2019
Contact Information	1800 251 400 - Philips Customer Care Centre