BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0766-2013 · Initiated January 14, 2013

    Recall

    Recall Number
    Z-0766-2013
    Event Number
    64099
    Firm
    Tobii Assistive Technology, Inc.
    FEI Number
    3007873415
    Product Code
    ILQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 14, 2013
    Posted
    February 1, 2013
    Terminated
    July 6, 2016
    Address
    333 Elm St, Dedham, MA, 02026-4530

    Description

    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.

    Reason

    Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.

    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 [email protected].

    Distribution

    US Nationwide Distribution

    Quantity

    483 units