Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MRI Patient Monitoring System) 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-2013-RN-01325-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-16
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Upon power up, the ip5 may fail to produce audio. "audio" includes touch screen tones, qrs/spo2 modulation tones and audible alarms. all other functionality of the ip5 is unaffected (ie. waveforms, numeric values, visual alarm indications). this problem will only occur upon power up of the device. accordingly, the scenario where audio is present at the onset of monitoring and then is lost during monitoring will not occur.
  • 조치
    Philips Healthcare is providing users work around instructions to follow as an interim measure. A software update will be installed to correct the problem.

Device

  • 모델명 / 제조번호(시리얼번호)
    Philips Expression Information Portal (IP5) (secondary display control unit for the Expression MRI Patient Monitoring System)Serial Numbers: US23200375, US23200376, US23200377 ARTG Number: 189095
  • 의료기기 분류등급
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA