Events

ADVIA Centaur CP System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics 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
    36181
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1516-06
  • 사례 시작날짜
    2006-08-04
  • 사례 출판 날짜
    2006-09-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48143
  • 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
    Immunoassay Analyzer - Product Code JJE
  • 원인
    Sample/patient mis-identification (software defect)-the system can associate a test result and sample identification (sid) with an incorrect patient name when the patient demographics feature is used and the patient identification (pid) field is left blank.
  • 조치
    On 8/04/06, a Support Bulletin was e-mailed to all affected Bayer HealthCare LLC Branches worldwide in order to inform them of the issue and to provide them with instructions for this 'field correction' until the new software version is issued. A Customer Bulletin and Confirmation Form (FaxBack) were prepared and sent to the affected Bayer Healthcare LLC Branches on 8/04/06 for communication with the affected customers worldwide.

Device

ADVIA Centaur CP System

Manufacturer

Siemens Healthcare Diagnostics
  • 제조사 주소
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA