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.
This recall has been terminated (originally issued June 29, 2011).
- Company
- Tobii Assistive Technology, Inc.
- Recall Initiated
- May 31, 2011
- Posted
- June 29, 2011
- Terminated
- October 1, 2012
- Recall Number
- Z-2694-2011
- Quantity
- 2430 units
- Firm Location
- Dedham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Lithium Batteries may overheat and become combustible
Distribution
USA (nationwide)
Lot / Code Info
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
Root Cause
Environmental control
Action Taken
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.