| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00526-1 |
| Product Name/Description |
PET VCAR Application Software (installed on Advantage Workstation and AW Server versions: Advantage Workstation 4.6, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 )
ARTG number: 153390 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
When using a customised PET VCAR PERCIST protocol with more than 1 target lesion selected for response calculation, the software may compute an incorrect response percentage and/or criteria whereby the number of lesions used to calculate response on the prior study is different than the number of lesions used to calculate response on the follow-up study. In which case, the response criteria generated under this condition will compare the sum of the target findings from the prior to the sum of findings on the follow-up study resulting in an incorrect response percentage. This error could lead to an incorrect response criteria categorisation [i.e. A patient that is responding to treatment (Partial Metabolic Response - PMR) could be categorised as not responding (Stable Metabolic Disease - SMD) or progressive (Progressive Metabolic Disease - PMD).] Miscategorisation of this type could lead to changes in the course of patient treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that when using PERCIST for treatment and therapy assessment, they should use the “Highest only” Target Lesions selection within the custom preset or use the default PERCIST_1.0 preset provided with the software. If site specific custom protocols are being used, customers are advised to implement temporary work around instructions. GE Healthcare will correct all affected systems once a software update is available which is expected to be released in July 2013. |
| Contact Information |
1300 722 229 - GE Healthcare National Service and Support Centre |