Events

Retiro De Equipo (Recall) de Ventana Medical System's Symphony Staining System

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
    45437
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0300-2008
  • Fecha de inicio del evento
    2007-09-06
  • Fecha de publicación del evento
    2008-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65469
  • 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
    in vitro diagnostic - Product Code KEY
  • Causa
    Shock hazard: devices released prior to full testing; the configuration of the symphony instrument during hi pot testing procedures did not completely evaluate all components in the test loop. in specific circumstances, a shock hazard exists.
  • Acción
    On 9/6/07, the firm began visiting customers to perform the HiPot test. Prior to performing the High Potential Test of Symphony Instruments already in the Field, the Field Service Engineer or FSE ensures that the customer fully understands the purpose of the test and why it is necessary to perform the test at their site. The FSE conveys the following points regarding the HiPot test: - The HiPot test is a safety verification for the electrical path within the instrument. - The HiPot test was performed incorrectly during the manufacturing process. - The HiPot test is used to verify that if a high voltage overload condition were to occur it would not lead to a short/arc within the instrument, which could pose a risk to anyone that touches the instrument - The HiPot test places a voltage of 2,000VDC onto the high voltage path of the instrument and if any of the insulating components are compromised, the tester will notify the FSE of the condition. - If the instrument fails the HiPot test, the faulty component will be replaced and the instrument will be retested until it passes. - Due to the high voltage used the during the test, no one will be allowed to touch the instrument until the test is complete. The FSE performing the test documents that the customer was informed of the reason for the High Potential Test on their Field Service Report.

Device

Ventana Medical System's Symphony Staining System
  • Modelo / Serial
    Serial Numbers: 910006-910011, 910013-910016, 910019, 910020, 910022, 910023, 910029, 910031-910033, 910036, 910049, 910053, 910054, 910056, 910057, and 910060.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA, Japan and France
  • Descripción del producto
    Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ
  • 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