Events

Philips HeartStart MRx cardiac monitor / defibrillator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-2012-RN-00735-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-07-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00735-3
  • 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
    Due to a corrupt data card some heartstart mrx defibrillator/monitors manufactured within these time periods may have incomplete 12-lead program files, and if so will present the following behaviour:- the device cannot analyse a 12-lead ecg report. due to this a user cannot view, print or transmit a 12-lead ecg.- a message 'cannot analyse ecg' is displayed on the mrx when an attempt to acquire a 12-lead report is made.
  • 조치
    User may continue to use an affected device, however the 12 lead report will not be generated, Philips Healthcare recommends have a back up device available. Philips Healthcare will be providing a software update to permanently correct the issue.

Device

Philips HeartStart MRx cardiac monitor / defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart MRx cardiac monitor / defibrillator, model number: M3536A with R.03.03 software and 12 Lead option (manual defibrillator)Model number: M3536A with R.03.03 software and 12 Lead option (or with the capability to install 12 lead option)Manufactured between April 17 2012 and May 8 2012Multiple serial numbersARTG number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA