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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00739-3
Product Name/Description Brilliance series 6, 16, 40, 64, CT Big Bore, iCT and iCT SP (CT systems)

Affected Serial Number ranges: 3669 - 3709, 5990 - 6176, 9258 - 9268, 10140 - 10300, 7445 - 7514, 200006 - 200038 & 100113 - 100170

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/07/2012
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue In the CT systems listed, 16 bolts secure J-brackets which support the carbon table top to the couch subframe. Philips Healthcare received two complaints stating that the bolt heads of several of these sixteen bolts had broken off.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare is providing users with work around instructions and will be replacing the bolts on the affected systems to permanently fix the issue.
Contact Information 1800 251 400 - Philips Customer Care Centre