Events

3.0T GE 6-Channel Phased Array Flex Coil 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia Pty Ltd 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
    RC-2017-RN-01349-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01349-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    Ge healthcare has recently become aware of a potential safety issue with the 3.0t 6 channel flex coil used with the 3t mr750w surgical suite scanners. coil overheating can occur when the device is used in mode 2 setup. this could lead to a serious patient thermal injury.To date, there have been no injuries reported as a result of this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • 조치
    GE Healthcare advised users to discontinue placing coil cables exiting towards the patient's feet. Users can continue to use Mode 1. GE Healthcare have corrected all affected units.

Device

3.0T GE 6-Channel Phased Array Flex Coil
  • 모델명 / 제조번호(시리얼번호)
    3.0T GE 6-Channel Phased Array Flex CoilProduct Code: M0050SSARTG Number: 132706
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd