Events

SIGNA Creator and SIGNA Explorer (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-01212-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01212-1
  • 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
    The function of rf power monitor is to monitor the rf amplifier output power, and detect if rf transmit power exceeding the predicted amount is generated. if the rf amplifier output power exceeds the predicted sar (specific absorption rate) amount, the rf power monitor will stop the scan. if the user performs a tps (transceiver processing and storage) reset during a patient scan, the rf power monitor will be disabled for the remainder of that patient scan. this would prevent the power monitor from detecting any subsequent failure of rf transmit function. these two failures together, could result in higher than expected thermal dose to the patient and higher than expected localised heating. there have been no failures of this type reported, and no injuries reported as a result of this issue.
  • 조치
    GE Healthcare is advising users they may continue to use the system, but ensure the RF power monitor is re-enabled by initiating a new patient exam if a TPS reset is performed during a patient exam. A software upgrade will be installed as a permanent correction. This action has been closed-out on 18/05/2017.

Device

SIGNA Creator and SIGNA Explorer (MRI System)

Manufacturer

GE Healthcare Australia Pty Ltd