Events

PRN 50-M+ Digital Writer 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-00149-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00149-1
  • 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 manufacturer has recently become aware of a potential safety issue associated with the flammability and fluid ingress rating of the outer enclosure material. there is an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the prn 50-m+ digital writer to meet its intended flammability and fluid ingress rating.
  • 조치
    GE Healthcare is replacing all affected printers with unaffected units. This action has been closed-out on 22/02/2017.

Device

PRN 50-M+ Digital Writer
  • 모델명 / 제조번호(시리얼번호)
    PRN 50-M+ Digital Writer Part Number: 600-23310-01 Units manufactured from May 28, 2013 through to April 7, 2015Serial Numbers: 1801405 through 1918761ARTG Number: 117497
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd