Retiro De Equipo (Recall) de 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 )

Recall

RC-2013-RN-00526-1

Class I

2013-05-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00526-1

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.

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.