BEUDAMED
    FDA Enforcement Class II 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 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0766-2013
    Event ID
    64099
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tobii Assistive Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    January 14, 2013
    Classification Date
    February 1, 2013
    Termination Date
    July 6, 2016
    Address
    333 Elm St, N/A, Dedham, MA, 02026-4530, United States

    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.

    Code Info

    Product Code 510410. All units.

    Distribution

    US Nationwide Distribution

    Quantity

    483 units