Events

ADVIA 1200 System Software: 1) V2.00, 2) V2.01 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
    66069
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0343-2014
  • 사례 시작날짜
    2013-09-03
  • 사례 출판 날짜
    2013-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121782
  • 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
    Electrode, ion specific, sodium - Product Code JGS
  • 원인
    Siemens healthcare diagnostics issued a urgent medical device correction due to ration parameters flagging behavior for all software versions utilized on advia 1200, 1650, 1800 or 2400 chemistry systems.
  • 조치
    On September 3, 2013, Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice for the ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems due to a software issue. The software issue has caused the Chemistry Systems to generate reports without error flags. Notices were sent to domestic customers via U.S. and outside the US the distribution is determined at the country level. The customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue at 877-229-3711 (prompt 18).

Device

ADVIA 1200 System Software: 1) V2.00, 2) V2.01
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 1) 10386841, 2) 10469445
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
  • 제품 설명
    ADVIA 1200 System Software: 1) V2.00, 2) V2.01. || Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

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