BEUDAMED
    FDA Recall Terminated

    BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger

    Recall: Z-0467-2013 · Initiated October 26, 2012

    Recall

    Recall Number
    Z-0467-2013
    Event Number
    63646
    Firm
    iwalk inc
    FEI Number
    3008869754
    Product Code
    ISW
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    October 26, 2012
    Posted
    December 4, 2012
    Terminated
    September 26, 2014
    Address
    4 Crosby Dr, Bedford, MA, 01730-1402

    Description

    BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger

    Reason

    Battery may over-heat during charging and smoke

    Action

    iWalk notified customers directly by sales representatives by telephone on October 26, 2012, and instructedthem to stop use of the battery and charger and return them to iWalk. Accounts provided with Return Material Authorizations (RMA). For questions regarding this recall call 781-761-1560.

    Distribution

    Nationwide Distribution including OH, NC, and NY.

    Quantity

    21 Batteries; 9 Chargers