Events

Retiro De Equipo (Recall) de Device Recall Juno DFR Xray 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 Villa Radiology Systems LLC.

¿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
    70241
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1079-2015
  • Fecha de inicio del evento
    2014-12-14
  • Fecha de publicación del evento
    2015-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132618
  • 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
    Table, radiologic - Product Code KXJ
  • Causa
    The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality.
  • Acción
    Planned Action by the firm: 1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge. 2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR The system shall be modified upgrading the generator power firmware which will inhibit the high-level control bringing the system into compliance. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will implement the corrective software patch to inhibit high-level control according to the corrective action plan by June 22, 2015. For further questions please 203.262-8836

Device

Device Recall Juno DFR Xray system
  • Modelo / Serial
    P/N 709020
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.
  • Descripción del producto
    Juno DFR X-ray system
  • Manufacturer
    Villa Radiology Systems LLC

Manufacturer

Villa Radiology Systems LLC
  • Dirección del fabricante
    Villa Radiology Systems LLC, 91 Willenbrock Rd Ste B1, Oxford CT 06478-1036
  • Empresa matriz del fabricante (2017)
    Villa Radiology Systems Llc
  • Source
    USFDA