Events

Device Recall CentraLink Data Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, 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
    70078
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0987-2015
  • 사례 시작날짜
    2014-12-16
  • 사례 출판 날짜
    2015-01-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132219
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • 원인
    Enabling sending of preliminary/initial results on the advia chemistry xpt creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on centralink. a result could be erroneous and critical and appear to be verified upon repeat.
  • 조치
    A Siemens service provider visited each site to verify and/or update customer configuration on the ADVIA Chemistry XPT and CentraLink Systems to ensure proper reporting of results. An Urgent Medical Device Correction letter was issued on December 16, 2014 to all affected customers. Customers were also provided a Customer Bulletin providing instructions on how configuration setting should remain.

Device

Device Recall CentraLink Data Management System
  • 모델명 / 제조번호(시리얼번호)
    CentraLink" Data Management System V14x Catalog Numbers: 10817209, 10818262
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in the state of WA.
  • 제품 설명
    ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA