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U.S. Department of Health and Human Services

Class 2 Device Recall P10 Tobii battery pack

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  Class 2 Device Recall P10 Tobii battery pack see related information
Date Initiated by Firm January 14, 2013
Date Posting Updated February 01, 2013
Recall Status1 Terminated 3
Recall Number Z-0766-2013
Recall Event ID 64099
Product Classification System, communication, powered - Product Code ILQ
Product P10 Tobii battery box (product number 510410)

Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
Code Information Product Code 510410. All units.
Recalling Firm/
Tobii Assistive Technology, Inc.
333 Elm St
Dedham MA 02026-4530
For Additional Information Contact Lyle Sherwood
781-461-8200 Ext. 266
Manufacturer Reason
for Recall
Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The recalling firm, Tobii Assistive Technology, Inc. sent a notification letter to all customers who received the recalled product via certified mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediatley discontinue the use of the P10 battery pack and provded with instructions to receive a complimentary replacement solution. The letter instructed customers to dispose of their P10 External Battery Pack in a manner stipulated with local laws. An acknowledgment form is included to be completed by customers. For questions contact Tobii ATI at 1-800-793-9227 or P10batterypack@tobiiati.com.
Quantity in Commerce 483 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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.