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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00555-1
Product Name/Description	Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SP Multiple product codes affected ARTG Number: 98868 Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore Multiple product codes affected ARTG Number: 118077 Precedence SPECT/CT Multiple product codes affected ARTG Number: 117440
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	31/05/2013
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	The stated tolerance in the Instructions for Use Manual for the recorded scanner output (CTDIvol) that is used to approximate patient dose does not accurately represent all systems. On some systems, the measured CTDIvol value may fall outside of these stated tolerances. In a worst case scenario, there is the potential for the delivered dose to exceed the reported dose by an amount almost equivalent of a rescan.
Recall Action	Recall for Product Correction
Recall Action Instructions	Philips is providing their customers with additional information that clarifies published specifications and correlation of CTDIvol value measurement.
Contact Information	1800 251 400 - Philips Customer Care Centre