BEUDAMED
    FDA Recall Terminated

    Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.

    Recall: Z-2358-2015 · Initiated February 2, 2015

    Recall

    Recall Number
    Z-2358-2015
    Event Number
    71613
    Firm
    Invacare Corporation
    FEI Number
    3002889431
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 2, 2015
    Posted
    August 10, 2015
    Terminated
    September 14, 2015
    Address
    1 Invacare Way, Elyria, OH, 44035-4190

    Description

    Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.

    Reason

    The batteries used in the Invacare Pronto Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.

    Action

    Invacare sent an " Urgent Medical Device Recall " letter on April 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You should immediately contact your provider at the number below so a replacement batteries can be installed. If you have any questions concerning these instructions, please call Invacares recall support line at (877) 413-6008, Monday Friday, 8 a.m. 5 p.m. EST, for assistance. Visit www.invacare.com/recall for more information about this recall.

    Distribution

    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI., and to the countries of : AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO

    Quantity

    1,057 finished devices