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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 Recall
P10 Tobii battery pack
see related information
Date Posted February 01, 2013
Recall Status1 Open
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/
Manufacturer
Tobii Assistive Technology, Inc.
333 Elm St
Dedham, Massachusetts 02026-4530
Consumer Instructions Contact the recalling firm for information
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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