Events

Siemens EasyLink 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
    68965
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2561-2014
  • 사례 시작날짜
    2013-08-13
  • 사례 출판 날짜
    2014-09-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129137
  • 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
    May not perform as intended under certain conditions, causing the release of results to the laboratory information system (lis) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the lis.
  • 조치
    Siemens issued an Urgent Medical Device Correction (UMDC) letter on August 13, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review this letter in its entirety and ensure that all operators understand the information presented. The issues described are specific to the features listed in the letter.. If the laboratory is not using a particular feature, then they are not affected by the issues described for that feature. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Siemens EasyLink Data Management System
  • 모델명 / 제조번호(시리얼번호)
    EasyLink Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799, 10444800, 10487219
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Siemens EasyLink Informatics System V4.0/V5 || Siemens, Material Number (SMN) || 10444799, 10444800, 10487219 || A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.
  • 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