Events

MSK 1.5T Extreme and Optima MR430s (MRI Systems) 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-00652-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00652-1
  • 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
    A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. there have been no injuries reported as a result of this issue. at this site, a magnet heater probe connection became disconnected. this resulted in ice build-up within the magnet blocking the cryogen vent. since the vent was blocked by ice, the later magnet quench caused gas to be vented into the magnet room.
  • 조치
    GE Healthcare is advising users to notify GE Service Engineer if the Magnet Monitoring Unit (MMU) detects any abnormal or out of specification reading. If the Magnet Monitoring Unit (MMU) detects an error it will display a pop-up window on the system monitor which will be seen by the operator. MMU reported errors will be in the form of a CAS7XX error (XX being the specific error) with a brief description. If no Magnet Monitoring Unit errors are reported, there are no action is required. Users can continue normal use of the affected products. GE will be correcting all affected units. This action has been closed out on 13 Jun 2017.

Device

MSK 1.5T Extreme and Optima MR430s (MRI Systems)
  • 모델명 / 제조번호(시리얼번호)
    MSK 1.5T Extreme and Optima MR430s (MRI Systems)ARTG Number: 193173
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd