Events

Retiro De Equipo (Recall) de Enaly 1000 BT12 Ozone Generator

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 William C. Domb, D.M.D., A Professional Corporation.

¿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
    68143
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1576-2014
  • Fecha de inicio del evento
    2014-04-23
  • Fecha de publicación del evento
    2014-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127001
  • 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
    Unit, operative dental - Product Code EIA
  • Causa
    William domb is recalling the enaly 1000 bt-12 ozone generator because it is not approved or cleared by the fda for medical use.
  • Acción
    William Domb, DMD sent an Urgent Medical Device Recall letter on April 23, 2014, to all affected customers who purchased the Enaly 1000BT-12 Ozone Generator. The letter informed the customers of the problems identified, risk to health, and the actions to be taken. Customers were instructed to discontinue use of the Enaly 1000 BT-12 Ozone Generator and return their units to the following address: William Domb, DMD 190 N Mountain Avenue Upland, CA 91786 Customers were also instructed to complete the Medical Device Field Action Return Response form. For questions customers should contact William Domb at (909) 949-2968 or by email at bill@smilestudio.com from Monday-Friday at 8am-5pm Pacific Time. For questions regarding this recall call (909) 949-2968.

Device

Enaly 1000 BT12 Ozone Generator
  • Modelo / Serial
    Lot # 10BT-091237
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.
  • Descripción del producto
    Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 || The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output.
  • Manufacturer
    William C. Domb, D.M.D., A Professional Corporation

Manufacturer

William C. Domb, D.M.D., A Professional Corporation
  • Dirección del fabricante
    William C. Domb, D.M.D., A Professional Corporation, 190 N. Mountain Ave., Upland CA 91786
  • Source
    USFDA