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.
FDA Recall Z-2694-2011 · Posted 2011-06-29
Recalling FirmTobii Assistive Technology, Inc.
Recall StatusTerminated
Product CodeILQ
Date Initiated2011-05-31
Date Terminated2012-10-01
Product Quantity2430 units
Reason for Recall
Lithium Batteries may overheat and become combustible
Firm 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.
Root Cause
Environmental control
Distribution Pattern
USA (nationwide)
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.