Events

Device Recall Ventana Image Analysis System (VIAS) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ventana Medical Systems 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
    45798
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0571-2008
  • 사례 시작날짜
    2007-06-26
  • 사례 출판 날짜
    2008-03-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66172
  • 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
    Pathology Image Analysis System - Product Code NQN
  • 원인
    Incomplete upgrade: the software upgrade from february 1, 2007 may not have been completed. this software upgrade adds the algorithm (slidetype) for the pathway anti-her-2/neu (4b5) antibody to the vias system.
  • 조치
    Beginning in 6/07, Ventana Medical Systems, Inc., made phonecalls to labs asking to confirm software version, date of upgrade if available and confirmation of whether site uses 4B5 and Imaging together. A phone script was provided. Customers with systems not ugraded were to upgrade before further use of system. A notification letter dated 8/17/2007 was later sent to VIAS customers advising that the software upgrade from February 1 , 2007 may not have been completed on their system. This software upgrade adds the algorithm (Slidetype) for the PATWAY anti-HER-2/neu (4B5) antibody to their VIAS system . This Slidetype is cleared for marketing and is required prior to imaging slides stained with PATHWAY anti-HER-2/neu (4B5). The letter also advises that their VIAS and NEXES systems are conneded to the internet which enables this upgrade to be performed remotely with the support of the Ventana Medical Systems Customer Support Center (CSC). customers are instructed to call the CSC to carry out the upgrade or to schedule a Technical Applications Specialist (TAS) to assist with the upgrade in their lab. Arrangements for the upgrade are to be made prior to imaging slides stained with PATHWAY anti-HER-2/neu (4B5).

Device

Device Recall Ventana Image Analysis System (VIAS)
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  HIS06086 HIS05042 HIS06047 HIS05018 HIS05022 HIS06046 HIS06092 HIS06059 HIS06053 HIS05053 HIS06035 HIS06038 HIS05026 HIS06100 HIS06021 HIS06074 HIS05041 HIS05017 HIS06031 HIS05051 HIS06061 HIS06028 HIS05011 HIS06083 HIS06064 HIS06057 HIS06055 HIS05047 HIS05012  HIS06054 HIS06073 HIS06088 HIS06076  HIS06002  HIS06001 HIS06004 HIS06034 HIS06015 HIS06098  HIS06069  HIS05044  HIS06033 HIS06050 HIS05046 HIS06030 HIS06095 HIS06067 HIS05028 HIS06027 HIS06056 HIS05033  HIS06049 HIS06026 HIS06008  HIS05049 HIS05013 HIS06079 HIS06072 HIS06089 HIS06084 HIS06044 HIS06007 HIS05027 HIS06051 HIS06052 HIS05025 HIS06096 HIS06066 HIS06039 HIS06065 HIS06019 HIS05052 HIS06029 HIS06022 HIS06068 HIS05048, and  HIS05058
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada
  • 제품 설명
    Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • 제조사 주소
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755-1962
  • 제조사 모회사 (2017)
    Roche Holding Ag
  • Source
    USFDA