FDA Recall Terminated

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.

Recall: Z-2694-2011 · Initiated May 31, 2011

Recall

Recall Number
Z-2694-2011
Event Number
58912
Firm
Tobii Assistive Technology, Inc.
FEI Number
3007873415
Product Code
ILQ
Status
Terminated
Root Cause
Environmental control
Initiated
May 31, 2011
Posted
June 29, 2011
Terminated
October 1, 2012
Address
333 Elm St, Dedham, MA, 02026-4530

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.

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 [email protected]. Contact the firm by E-mail: [email protected] or telephone: 1-800-793-9227.

Distribution

USA (nationwide)

Quantity

2430 units