Events

Device Recall Alaris PC Unit 8015 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carefusion Corporation 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
    64728
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1098-2013
  • 사례 시작날짜
    2013-03-06
  • 사례 출판 날짜
    2013-04-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116871
  • 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 recall was initiated because carefusion has received reports of a communication error on the alaris pc unit model 8015 with software version 9.12 when the alaris etco2 module or alaris spo2 module is attached.
  • 조치
    CareFusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. Customers are required to confirm receipt of the notification by returning the Recall Response card to Carefusion by postage-paid, self-addressed mail, fax, or email. Carefusion representatives will contact customers by telephone to schedule field remediation. For questions contact CareFusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266 and/or Technical Support at 888-812-3229.

Device

Device Recall Alaris PC Unit 8015
  • 모델명 / 제조번호(시리얼번호)
    unit model 8015 with software version 9.12
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia and China.
  • 제품 설명
    Alaris PC unit model 8015 with software version 9.12 || Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
  • Manufacturer
    Carefusion Corporation

Manufacturer

Carefusion Corporation
  • 제조사 주소
    Carefusion Corporation, 3750 Torrey View Ct, San Diego CA 92130-2622
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA