Events

Retiro De Equipo (Recall) de Device Recall NeoMedix Trabectome I/A

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 Neomedix Corp.

¿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
    48721
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0071-2008
  • Fecha de inicio del evento
    2007-05-28
  • Fecha de publicación del evento
    2008-09-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72004
  • 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
    surgical aspirator - Product Code BTA
  • Causa
    Failure of irrigation flow: the pinch valve in a few pumps may not consistently open to allow irrigation flow. in over 450 surgeries, the firm confirmed one instance of a valve that did not open. the electrically activated pinch valve in the neomedix trabectome i/a pump activates irrigation flow to the eye during trabectome surgery.
  • Acción
    On May 31, 2007 NeoMedix mailed a Customer letter to all consignees informing them of the hazard. The letter also indicated to the customers they NeoMedix has developed a minor modification/upgrade that is designed to assure that the pinch valve opens at the appropriate time. The customers were instructed this modification requires return of their existing pump for modification and testing at the firm's facility before its return. In the event that surgeries have already been scheduled, NeoMedix will provide a loaner unit until the suspect unit can be modified and returned to you. The letter also indicated the cost of the modification and/or use of a loaner unit will be entirely at NeoMedix expense. You will be contacted to establish the details of implementing this modification.

Device

Device Recall NeoMedix Trabectome I/A
  • Modelo / Serial
    Model Number 550014; Lot Number 061205-1; Serial Numbers: 10117, 10119, 10120, 10122, 10124, 100129, and 10133.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide to: CA, HI, IA, NY & PA
  • Descripción del producto
    NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
  • Manufacturer
    Neomedix Corp

Manufacturer

Neomedix Corp
  • Dirección del fabricante
    Neomedix Corp, 15042 Parkway Loop Ste A, Tustin CA 92780-6528
  • Empresa matriz del fabricante (2017)
    Neomedix Corporation
  • Source
    USFDA