Events

Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Masimo 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-2013-RN-00379-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00379-1
  • 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
    Masimo has identified a very small number of rad-8 devices that, when moved, can power off without the operator pressing the power button. if a change in power status goes unnoticed by the caretaker, a delay of care could result.This recall action was not notified to the tga before it was initiated by masimo australia.
  • 조치
    Masimo is providing two options to the customers for correction and removal. The first option is to return the Rad-8 devices for Masimo for repair. The second option is for a biomedical engineer employed by a customer to repair the device in the field once qualified by Masimo to do so. This action has been closed-out on 11/02/2016.

Device

Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013
  • 모델명 / 제조번호(시리얼번호)
    Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013Device Identifiers: 1844, 1959, 1961, 1963, 22042, 22595, 3446, 9019, 9049, 9073, 9165, 9174, 9190, 9212, 9224,1845, 1960, 1962, 1964, 9020, 9050, 9074, 9166, 9175, 9191, 9213, 9192, 9194, 9193, 9195ARTG Number: 138873
  • Manufacturer
    Masimo Australia Pty Ltd

Manufacturer

Masimo Australia Pty Ltd