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

FDA device recall Z-2694-2011 · posted 2011-06-29 · Terminated

Recall details

Recalling firm

Tobii Assistive Technology, Inc.

Reason for recall

Lithium Batteries may overheat and become combustible

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.

Root cause

Environmental control

Status

Terminated

Product code

ILQ

Quantity affected

2430 units

Distribution

USA (nationwide)

Date initiated

2011-05-31

Date posted

2011-06-29

Date terminated

2012-10-01

Location

Dedham, MA