Events

GC80 Diagnostic X-Ray system 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Samsung Electronics 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-00653-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00653-1
  • 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
    An incident had been reported in germany to samsung electronics on 15 dec 2016 where an image was obtained with over exposure during a thorax examination using the aec function. the exposure condition was: 125kv, 180mas.As a result of the malfunction of the aec, irradiation may not terminate properly which can cause exposure until the aec back up time which is set at 500msec by default. this can cause overexposure for users.
  • 조치
    Samsung will be implementing a software update on affected units in early July 2017. In the interim, users are advised that they may continue to use the GC80 system, taking precaution of any possible network disconnection between the THU and WS. Users are requested to check 1) the THU connection status when using the system and 2) the THU connection before logging in after system booting. (Please refer to recall notification for images and further details).

Device

GC80 Diagnostic X-Ray system

Manufacturer

Samsung Electronics Australia Pty Ltd