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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