Events

FC 500 with CXP Acquisition Software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    49010
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0455-2009
  • 사례 시작날짜
    2007-08-01
  • 사례 출판 날짜
    2009-01-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72513
  • 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
    Automated Differential Cell Counter - Product Code GKZ
  • 원인
    Software error: the recall was initiated after beckman coulter identified that the cxp user documentation does not adequately characterize the use of the live gate feature. the primary use of a live gate is for the international removal of unwanted events, such as debris. the data outside of the live gate will not be stored to the final listmode file, this reducing the data set size. the softwa.
  • 조치
    The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321.

Device

FC 500 with CXP Acquisition Software
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers 626553, Version 2.2
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Globally to the United States and Canada.
  • 제품 설명
    Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • 제조사 주소
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA