Events

Recall of AW VOLUMESHARE 5 - VOLUME VIEWER OPTIONS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    58887
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    When using a customized 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 categorization [i.E. a patient that is responding to treatment (partial metabolic response - pmr) could be categorized as not responding (stable metabolic disease - smd) or progressive (progressive metabolic disease - pmd).] miscategorization of this type could lead to changes in the course of patient treatment.

Device

AW VOLUMESHARE 5 - VOLUME VIEWER OPTIONS
  • Model / Serial
    Model Catalog: 5422769-X (Lot serial: 00000LA713783D); Model Catalog: 5422769-X (Lot serial: 00000L3A330899); Model Catalog: 5422769-X (Lot serial: 00000L3A87FE86); Model Catalog: 5422769-X (Lot serial: 00000L3A86843C); Model Catalog: 5422769-X (Lot serial: 00000L3A3305A1); Model Catalog: 5422769-X (Lot serial: 00000LA703D3E9); Model Catalog: 5422769-X (Lot serial: 00000LA7142C7C); Model Catalog: 5422769-X (Lot serial: 00000LA712A01B)
  • Product Description
    PET VCAR
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)