Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00812-3
Product Name/Description Brilliance 64 and Ingenuity CT systems with software version 4.0.0.xx379 (Full body diagnostic CT X-ray system)

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 8/08/2012
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The following issues have been identified with this product:

1. The current system design of software version 4.0.0.xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion Scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after entering their credentials and password

2. When service providers gain a remote connection to the scanner, the scanner does not notify the user that remote access of the system is in effect

3. When the interventional biopsy protocol is used, the manual button is enabled on the CT control, but when the user presser the "Go" button on the gantry, it may produce multiple scans

4. The table and the gantry could get close enough to each other (<25mm apart) which poses the risk of 'pinching' a patient's or technologist's finger.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is providing a software update to permanently correct the issues.
Contact Information 1800 251 400 - Philips Customer Care Centre