Events

Retiro De Equipo (Recall) de Device Recall Tobii CSeries Lithium Batteries

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 Tobii Assistive Technology, Inc..

¿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
    58912
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2694-2011
  • Fecha de inicio del evento
    2011-05-31
  • Fecha de publicación del evento
    2011-06-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100584
  • 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
    Lithium batteries may overheat and become combustible.
  • Acción
    Tobii Technology AB sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were advised to stop using the batteries and to remove them from their devices. They were instructed to dispose of the batteries in an environmentally responsible manner as hazardous materials. Tobii will replace the affected batteries. Customers were asked to complete and return an acknowledgement form via fax at 781-461-8213 or e-mail at recall@tobiiati.com. Contact the firm by E-mail: recall@tobiiati.com or telephone: 1-800-793-9227.

Device

Device Recall Tobii CSeries Lithium Batteries
  • Modelo / Serial
    Serial numbers starting with: TCBSS Battery standard for C8 (old version) =TB8A TCBSH Battery HiCapacity for C8 (old version)=TB8B TCBLS Battery standard for C12 (old version)=B12A
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide)
  • Descripción del producto
    Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices. || Communication device for the impaired and functions as a speech generating device; text or symbols can be used to generate synthesized or digitized speech. Perfect for asking or answering questions, having a conversation.
  • Manufacturer
    Tobii Assistive Technology, Inc.

Manufacturer

Tobii Assistive Technology, Inc.
  • Dirección del fabricante
    Tobii Assistive Technology, Inc., 333 Elm St, Dedham MA 02026-4530
  • Source
    USFDA