Events

AW VOLUMESHARE 5 - VOLUME VIEWER OPTIONS 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE) 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58887
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-05-08
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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
  • 모델명 / 제조번호(시리얼번호)
    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)
  • 제품 설명
    PET VCAR
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)