Events

Device Recall Alaris PC unit model 8000 and 8015 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CareFusion 303, Inc. 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
    66865
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0534-2014
  • 사례 시작날짜
    2013-12-05
  • 사례 출판 날짜
    2013-12-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-06-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123822
  • 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
    Pump, infusion - Product Code FRN
  • 원인
    Carefusion is recalling the alaris pc unit (model 8000 and 8015) because the alaris pc unit will produce an audible alarm and the alaris pc unit will display a system error message.
  • 조치
    CareFusion sent an Urgent Medical Device Recall Notification letter dated December 5, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to contact CareFusion Customer Advocacy at (888) 812-3266, if they experienced a SYSTEM ERROR on the Alaris PC unit. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to complete and return the enclosed Customer Response Card to expedite the corrective action process. Customers with questions were instructed to contact CareFusion Support Center at 888-562-6018, or for Technical Support call 888-812-3229.

Device

Device Recall Alaris PC unit model 8000 and 8015
  • 모델명 / 제조번호(시리얼번호)
    not available
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.
  • 제품 설명
    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. || Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • 제조사 주소
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA