Events

Discovery MR750w (MRI System) 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-00773-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00773-1
  • 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 patient bore heating on the discovery mr750w. a small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. this issue has been observed in the situation in which a user has routinely used the system for off center imaging with large patients (for example, off center wrist or shoulder exams) with transmit gain set near maximum levels. there have been no reports of injury as a result of this issue.
  • 조치
    GE is advising users to continue to use the system and follow the existing Operator Safety Information for proper patient padding and observation during scanning. If a brown discolouration is seen on the inner surface of the patient bore or if a burning smell is noticed, discontinue scanning. GE will be correcting all affected units.

Device

Discovery MR750w (MRI System)

Manufacturer

GE Healthcare Australia Pty Ltd