Events

Monitor AC2000 Spring Arm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Draeger Medical 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-2014-RN-00406-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00406-1
  • 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
    Draeger medical australia has been informed of three cases where a welded seam in the spring-loaded arm of the monitor holder broke resulting in the monitor falling. although no injury has been reported, the risk of injury to persons positioned beneath the monitor cannot be excluded.
  • 조치
    A Drager service representative will inspect all potentially affected spring-loaded arms. A replacement arm will be provided for all devices determined to be affected.

Device

Monitor AC2000 Spring Arm
  • 모델명 / 제조번호(시리얼번호)
    Monitor AC2000 Spring ArmPart Numbers: G19051 and G19262All serial numbers affectedPart Number: G93358All serial numbers until 0111 066 23639 affectedPart Number: G93359All serial numbers until 0111 056 21343 affectedARTG Number: 132260
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd