Events

3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures) 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-2016-RN-00176-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00176-1
  • 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 gemflex coil manufactured by neocoil used with ge healthcare 3.0t scanners. part of the cable assembly may overheat when the device is used. there is a rare probability that this could result in minor burn injury in case of prolonged direct skin contact with the overheating part. so far there have been no injuries reported as a result of this issue.
  • 조치
    GE Healthcare is advising users to ensure the user instructions are followed in regards to using proper padding to avoid all direct contact of the patient with the cable. The device can continue to be used while GE are implementing a permanent correction. This action has been closed-out on 23/05/2017.

Device

3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses f...
  • 모델명 / 제조번호(시리얼번호)
    3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)Affected Products:3.0T GEM Flex Coil 16-L Array 5430008-23.0T GEM Flex Coil 16-M Array 5430008-33.0T GEM Flex Coil 16-S Array 5430008-43.0T GEM Flex Interface 5430008-5ARTG Number: 153134
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd