Device Recall Clinician Workstation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    31467
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0981-05
  • 사례 시작날짜
    2005-03-10
  • 사례 출판 날짜
    2005-07-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-02-06
  • 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
    Medical Computers And Software - Product Code LNX
  • 원인
    The medication administration results displayed in the 'view results' link may be inaccurate.
  • 조치
    Urgent Device Correction recall letters dated 3/10/05 were sent to the direct accounts on the same date via first class mail. The letter describes the inaccuracies in the 'View Results' program, and informed the accounts that inaccurate information could lead to incorrect clinical decision-making, which could impact a patient''s medication treatment protocol. The accounts were requested to disable the 'View Results' link until a software upgrade is available, and to inform all clinical point of care users that the 'View Results' has been disabled and that the Manual Adminstration Record is to be used as the primary source of information for reviewing medication adminstration results. The accounts were instructed to contact their account executive and/or the Client Support Services at 1-877-835-2727 for instructions on how to disable the 'View Results' feature.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product code 2M5042, software versions 3.4, 4.0 and 4.1
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Missouri, Massachusetts, Vermont, California and Canada.
  • 제품 설명
    Clinician Workstation Software, product code 2M5042
  • Manufacturer

Manufacturer

  • 제조사 주소
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA