Events

Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0 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-2018-RN-00026-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00026-1
  • 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
    Philips has been made aware of a potential problem with all piic ix surveillance and patient link revisions. the issue will occur after a surveillance station is first restarted during the year 2018. after that initial restart, the station will thereafter no longer perform patient discharge and transfer operations. any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the surveillance station during such restart.
  • 조치
    Philips is advising users that in order to avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. Users may use the workflows described in the attachment provided with the customer letter to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged.

Device

Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023...
  • 모델명 / 제조번호(시리얼번호)
    Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0ARTG 94237
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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