Events

Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96 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-2016-RN-00090-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-01-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00090-1
  • 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 st elevation alarm on the patient monitor or standalone x2 measurement module will not sound when indicated for all chest leads derived using hexad 12-lead ecg monitoring in the following host monitor configuration:st analysis: “off” ste: “on“ste alarms: “on”the problem only occurs if either of the affected philips intellivue measurement modules are used with philips intellivue patient monitors with hexad option #c54 (also bundled in options h11, h41, h42, cp2), or if an affected x2 measurement module is used in standalone mode (i.E., not connected to another monitor).There is potential for delay in diagnosis due to the monitor not alarming for st elevation on the chest leads.
  • 조치
    Philips Healthcare is advising users to ensure the ST Analysis is switched to ON when using STE measurement. A software upgrade will be installed as a permanent correction.

Device

Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versio...
  • 모델명 / 제조번호(시리얼번호)
    Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96Affected Philips IntelliVue Measurement Modules:Model Number: X1Product Number: M3001A Software Revision: K.21.54 or L.00.96Model Number: X2Product Number: M3002A Software Revision: K.21.54 or L.00.96 ARTG Number: 94238
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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