FDA Medical Device Recalls (openFDA)
Tobii Assistive Technology, Inc.: 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 number
- Z-2694-2011
- Recalling firm
- Tobii Assistive Technology, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-05-31
- Posted
- 2011-06-29
- Terminated
- 2012-10-01
- Reason
- Lithium Batteries may overheat and become combustible
- Root cause
- Environmental control
- 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.
- Quantity
- 2430 units
- Distribution
- USA (nationwide)
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILQ
- Firm FEI
- 3007873415
- Firm city
- Dedham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28