| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01223-1 |
| Product Name/Description |
TumorLOC (intensity projection dataset software) use with: Brilliance CT Big Bore, EBW, GEMINI LXL, GEMINI TF 16, GEMINI TF 64 & GEMINI TF Big Bore (radiology systems)
Multiple affected serial numbers
ARTG Number: 117441 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
The TumorLOC application has the capability to generate intensity projection datasets from respiratory gated data. A circumstance has been identified where these generated datasets are flipped and incorrectly labelled left to right when they are saved to disk. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Work around instructions will be provided to customers to avoid the problem. A software update is under development and will be implemented once complete. This action has been closed-out on 11/04/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |