Events

Device Recall Siemens syngo(R) Lab Data Manager 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
    62403
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2173-2012
  • 사례 시작날짜
    2012-06-07
  • 사례 출판 날짜
    2012-08-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110419
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • 원인
    The recalling firm has discovered that when using a sysmex(r) ca-7000 or ca-1500 coagulation analyzer with the syngo lab data manager (ldm), there is a potential for the syngo ldm system, to display and transmit to the lis an incorrect result following the syngo ldm's application of the configured result number format. the problem is encountered when the result number format configured on the sys.
  • 조치
    Siemens Healtcare Diagnostics sent a Urgent Field Safety Notice dated June 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to discuss the contents of this letter with your Laboratory Director regarding the need to review any previous test results. If you have any technical questions or concerns, please contact the Seimens Technical Solutions Center at 1-800-441-9250, for further assistance.

Device

Device Recall Siemens syngo(R) Lab Data Manager
  • 모델명 / 제조번호(시리얼번호)
    Version VA11B and all previously released versions.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.
  • 제품 설명
    Siemens syngo(R) Lab Data Manager. || The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA