Z-2694-2011

Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech...

Name: Z-2694-2011 Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech...
Creator: Tobii Assistive Technology, Inc.
Published: 2011-05-31
License: https://open.fda.gov/license/

Tobii Assistive Technology, Inc. / initiated 2011-05-31 / Terminated / root cause: manufacturing process

FDA source

Tobii Assistive Technology, Inc. began a recall of Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices. Communication device for... on 2011-05-31. The reason FDA records is "Lithium Batteries may overheat and become combustible". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2694-2011
Status: Terminated
Initiated: 2011-05-31
Posted: 2011-06-29
Terminated: 2012-10-01
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.
Product code: ILQ System, Communication, Powered
Reason for recall: Lithium Batteries may overheat and become combustible
Root cause tag: manufacturing process
FDA 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 [email protected]. Contact the firm by E-mail: [email protected] or telephone: 1-800-793-9227.
Quantity in commerce: 2430 units
Distribution: USA (nationwide)
Product codes and lots: 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 code ILQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)