Device Recall eCare Coordinator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Visicu 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
    76660
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1708-2017
  • 사례 시작날짜
    2017-03-02
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
  • 원인
    Ecarecoordinator (ecc) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. the software is intended to provide patient information from the patient location through networking technology to a remote care team. a software defect was discovered in the philips ecarecoordinator (ecc) clinical user interface that can at times cause missing or redundant data to be saved without notification to the user.
  • 조치
    Field Safety Notice (FSN) will be sent to all customers using eCareCoordinator all Versions. The FSN describes the problem and circumstances in which the design defects occurs and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. A software correction will be made and released.by the vendor. Customers will have this correction applied to their current version when made available by Vendor in order to fix this correction.

Device

  • 모델명 / 제조번호(시리얼번호)
    453564506091  eCareCoordinator
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US Nationwide
  • 제품 설명
    eCare Coordinator || Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Philips Visicu, 217 E Redwood St Ste 1900, Baltimore MD 21202-3315
  • 제조사 모회사 (2017)
  • Source
    USFDA