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
    73673
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1557-2016
  • 사례 시작날짜
    2016-03-10
  • 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
    The adherence check generates a software error. two issues occur as a result of the software error: 1) no adherence flag is generated for that day; 2) no task is generated for the date 14 days later. an error message is generated and forwarded to operations. subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. if the pa.
  • 조치
    1. Field Safety Notice(FSN) will be sent to all customers using eCareCoordinator v.1.3 platform. The FSN describes the problem and the circumstances in which the design defects occur and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. 2. A software correction will be made and released. Customers will be upgraded to eCC v.1.4. The v.1.4 is scheduled to be released on or about 8 March 2016. The defect will have been corrected and tested.

Device

  • 모델명 / 제조번호(시리얼번호)
    453564506091 eCareCoordinator 1.3
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
  • 제품 설명
    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). || For medical use by professional medical staff.
  • Manufacturer

Manufacturer

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