Events

Device Recall Pyxis 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
    53991
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1015-2013
  • 사례 시작날짜
    2009-11-20
  • 사례 출판 날짜
    2013-03-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86996
  • 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
    Cabinet, table and tray, anesthesia - Product Code BRY
  • 원인
    The recall was initiated because carefusion has confirmed that when the pas 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
  • 조치
    Carefusion sent a Safety Alert Notification letter dated January 13, 2010 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to ensure back-up procedures were in place in case of system down-time or lock-up, including review of the back-up procedures with staff. The letter included an update to the PAS 2000 User Guide. The letterstates that a CareFusion field representative will be contacting customers to make arrangements to apply warning labels to the PAS 2000 electronics doors. Customers were instructed to complete and return the Response Card included. For questions contact your local field support representative ot the Advocacy department at customer.advocacy@carefusion.com.

Device

Device Recall Pyxis
  • 모델명 / 제조번호(시리얼번호)
    All Pyxis Anesthesia System Model 2000
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide) including CANADA.
  • 제품 설명
    Pyxis Anesthesia System Model 2000 (PAS 2000) || Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
  • Manufacturer
    CareFusion Corporation

Manufacturer

CareFusion Corporation
  • 제조사 주소
    CareFusion Corporation, 10020 Pacific Mesa Blvd, San Diego CA 92121
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA