Events

Recall of Device Recall Tobii CSeries Lithium Batteries

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tobii Assistive Technology, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58912
  • Event Risk Class
    Class 2
  • Event Number
    Z-2694-2011
  • Event Initiated Date
    2011-05-31
  • Event Date Posted
    2011-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100584
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, communication, powered - Product Code ILQ
  • Reason
    Lithium batteries may overheat and become combustible.
  • Action
    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
  • Model / 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
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide)
  • Product Description
    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.
  • Manufacturer Address
    Tobii Assistive Technology, Inc., 333 Elm St, Dedham MA 02026-4530
  • Source
    USFDA