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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01528-1
Product Name/Description Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/11/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue A complaint was received by Philips indicating that the non-gated bolus tracking clinical scan failed to initialise with the system displaying the error message:

“A problem has occurred; please retry. If the problem persists contact service.”

This resulted in the study being cancelled with a loss of bolus. If this were to re-occur, it may necessitate a rescan.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare will be installing a software update to correct the issue. A Philips Field Service Engineer will contact affected customers to schedule the software update installation at their site. In the interim, customers are advised that when failure occurs the users may :

1. Continue initiating the diagnostic scan manually.
2. Repeat the bolus tracker scan

Customers are also advised to use one of the workaround options provided in the customer letter to prevent the failure of non-gated Bolus Tracking clinical scans with dose modulation.

This action has been closed out on the 12/11/2018.
Contact Information 1800 251 400 - Philips Customer Care Centre