Events

Xper Flex Cardio 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-2015-RN-01105-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01105-1
  • 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 spo2 and non-invasive blood pressure (nibp) waveform and numeric values displayed on the device may freeze, resulting in the display of measurements that are not current. should this problem occur, spo2 and nibp will no longer function, including alarms. this may result in a delay in detecting important changes in a patient’s cardiovascular and respiratory condition.
  • 조치
    Philips is advising users that the devices can continue to be used provided that each monitored patient is closely observed by a qualified healthcare professional. A software upgrade will be installed on all affected devices as a permanent correction.

Device

Xper Flex Cardio Patient Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Xper Flex Cardio Patient Monitoring SystemModel Numbers: FC2010 and FC2020All systems distributed prior to September 2015ARTG Number: 229631
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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