Events

Retiro De Equipo (Recall) de Device Recall Ventana Image Analysis System (VIAS)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ventana Medical Systems Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    45798
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0571-2008
  • Fecha de inicio del evento
    2007-06-26
  • Fecha de publicación del evento
    2008-03-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66172
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Pathology Image Analysis System - Product Code NQN
  • Causa
    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.
  • Acción
    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)
  • Modelo / Serial
    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
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    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
  • Dirección del fabricante
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755-1962
  • Empresa matriz del fabricante (2017)
    Roche Holding Ag
  • Source
    USFDA