Events

Device Recall Siemens syngo(R) Lab Data Manager Version VA11B and VA12A 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
    65147
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0433-2014
  • 사례 시작날짜
    2013-05-10
  • 사례 출판 날짜
    2013-12-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118015
  • 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
    Under certain conditions the system may not perform as intended, causing the release of results to the laboratory information system 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 sent an Urgent Medical Device Correction letter in May 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the letter in its entirety and ensure that all operators understand the information presented. Specific actions needed to be implemented by the customer were outlined in the letter. Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.

Device

Device Recall Siemens syngo(R) Lab Data Manager Version VA11B and VA12A
  • 모델명 / 제조번호(시리얼번호)
    Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA (nationwide) and internationally to Canada.
  • 제품 설명
    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems || Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.
  • 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