Events

Retiro De Equipo (Recall) de Device Recall tobii dynavox

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 Dynavox 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
    79433
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1304-2018
  • Fecha de inicio del evento
    2017-12-14
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162310
  • 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
    System, communication, powered - Product Code ILQ
  • Causa
    The battery is integral to the device. if the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. the battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. this battery may cause the device case to separate a small amount.
  • Acción
    On February 26, 2018 an URGENT MEDICAL RECALL LETTER was issued to customers with the subject line listing the serial number specific to that customer along with the date of purchase. The letter informs customers of the issue and instructs customers to return product to one of their facilities to have the product repaired until an RA. Questions or concerns can be directed to 1-800-344-1778, Press 1 and then Press 2.

Device

Device Recall tobii dynavox
  • Modelo / Serial
    TS1308 TS1411  Part Numbers: T10: 750394  Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationally
  • Descripción del producto
    Dynavox T10 Speech Generating Device ( including Batteries)
  • Manufacturer
    Dynavox Systems Llc

Manufacturer

Dynavox Systems Llc
  • Dirección del fabricante
    Dynavox Systems Llc, 2100 Wharton St Ste Ste 400, Pittsburgh PA 15203-1691
  • Source
    USFDA