Events

AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Zoll 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-2016-RN-00618-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00618-1
  • 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, accriva diagnostics has confirmed that some avoximeter 1000e instruments shipped to customers from july 2015 and april 2016 may have been sent to customers with the diagnostic mode enabled. with the diagnostic mode enabled, users could mistakenly unlock features in the instrument software through a specific sequence of keystrokes. if these features are altered, there is a potential for erroneous results to be displayed. to date accriva has not received any reports of injuries or harm to users due to this issue. instruments in diagnostic mode perform per accriva’s specifications and all data generation is equivalent to those instruments properly set to user mode.
  • 조치
    Zoll Medical is providing instructions for users to be able to identify the affected instruments. In the case where an affected instrument is identified, users should contact Zoll Technical Services to correct the settings. This action has been closed-out on 03/02/2017.

Device

AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)
  • 모델명 / 제조번호(시리얼번호)
    AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)Product Code: AVOX1000ESerial Numbers: 5696-5725, 5816-5977ARTG Number: 262420
  • Manufacturer
    Zoll Medical Australia Pty Ltd

Manufacturer

Zoll Medical Australia Pty Ltd