Events

Nihon Kohden Defibrillator CardioLife, Model Number: TEC 5521 & 5531 (Semi-automated defibrillator) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Dancor Pty Ltd T/a Boab Medical Technologies 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-2012-RN-01070-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-10-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01070-1
  • 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 defibrillator will cease to work on dc power supply in a specific case (due to electrical damage to a protection circuit) when the battery is fully depleted and no longer able to hold a charge. there is no limitation for the operation of the defibrillator when the ac power is connected.
  • 조치
    Quarantine and return affected devices to Boab Medical for a software update.

Device

Nihon Kohden Defibrillator CardioLife, Model Number: TEC 5521 & 5531 (Semi-automated defibrillator)
  • 모델명 / 제조번호(시리얼번호)
    Nihon Kohden Defibrillator CardioLife, Model Number: TEC 5521 & 5531 (Semi-automated defibrillator)Serial Numbers: 01590, 00043 & 02082ARTG Number: 116745
  • Manufacturer
    Dancor Pty Ltd T/a Boab Medical Technologies

Manufacturer

Dancor Pty Ltd T/a Boab Medical Technologies
  • Source
    DHTGA