Events

Retiro De Equipo (Recall) de Device Recall eSwallow MultiProgram Dysphagia Therapy Test unit

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 eSwallow USA 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
    59178
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2880-2011
  • Fecha de inicio del evento
    2011-06-22
  • Fecha de publicación del evento
    2011-07-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101508
  • 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
    Stimulator, muscle, powered - Product Code IPF
  • Causa
    It was discovered that the firm was distributing medical devices without fda approval.
  • Acción
    eSwallow USA LLC sent an URGENT MEDICAL DEVICE RECALL letter dated June 22 2011, via US mail and email notification to each distributors. The letter identified the product, the problem, and the action to be taken. Distributors were instructed to immediately examine inventory, quarantine all product subject to recall, and identify customers that received these products and notify them at once of the recall. The letter advised distributors to forward a copy of the recall notification letter to their customers. The letter states that the distributors are to return all inventories to the eSwallow Corporate Office eSWALLOWusa, 106 Hidden Drive, Scottsboro, Al 35769. The recall should be carried out to the customer/user level. Customers are instructed to complete and return the attached Response Form as soon as possible. If you have any questions, call (256) 571-0443.

Device

Device Recall eSwallow MultiProgram Dysphagia Therapy Test unit
  • Modelo / Serial
    all lot numbers
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (USA) Distribution - including states of AL, AZ, CA, GA, FL, LA, MS, and VA.
  • Descripción del producto
    eSwallow Multi-Program Dysphagia Therapy Test unit || Intended Use: Powered Muscle Stimulator for treatment of dysphagia.
  • Manufacturer
    eSwallow USA LLC

Manufacturer

eSwallow USA LLC
  • Dirección del fabricante
    eSwallow USA LLC, 106 Hidden Drive, Scottsboro AL 35769-9322
  • Empresa matriz del fabricante (2017)
    Eswallow Usa Llc
  • Source
    USFDA