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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