Events

Recall of 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 )

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00526-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00526-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

PET VCAR Application Software (installed on Advantage Workstation and AW Server versions: Advanta...
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd