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U.S. Department of Health and Human Services

Class 2 Device Recall Tobii CSeries Lithium Batteries

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 Class 2 Device Recall Tobii CSeries Lithium Batteriessee related information
Date Initiated by FirmMay 31, 2011
Date PostedJune 29, 2011
Recall Status1 Terminated 3 on October 01, 2012
Recall NumberZ-2694-2011
Recall Event ID 58912
Product Classification System, communication, powered - Product Code ILQ
ProductTobii 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Tobii Assistive Technology, Inc.
333 Elm St
Dedham MA 02026-4530
For Additional Information ContactTara Rudnicki
781-461-8200 Ext. 266
Manufacturer Reason
for Recall		Lithium Batteries may overheat and become combustible
FDA Determined
Cause 2		Environmental control
ActionTobii 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 in Commerce2430 units
DistributionUSA (nationwide)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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