Events

Device Recall Alaris PC unit, Model 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
    73631
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1606-2016
  • 사례 시작날짜
    2016-03-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144638
  • 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
    The alaris pc units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (c245) at power up on the alaris pc unit logic boards.
  • 조치
    The firm, Carefusion, sent a "Medical Device Recall Notification" letter dated March 30, 2016 to its customers. The letter described the product, problem, the potential risk involved and the required action for users. The customers were instructed to do the following: If you observe System Error code 133.6080, remove the PC unit from use and contact the CareFusion Support Center, and promptly complete and return the enclosed Customer Response Card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018 from 7am-4pm PST, M-F, or by email at supportcenter@carefusion.com. Customers with clinical inquiries, product complaints, or clinical troubleshooting are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7 days/week or by email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PST, M-F or by email at dl-us-inf-techsupport@carefusion.com.

Device

Device Recall Alaris PC unit, Model 8015
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Australia, Great Britain and Canada.
  • 제품 설명
    Alaris PC unit, Model 8015 || The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
  • 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