BEUDAMED
    FDA Recall Terminated

    Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

    Recall: Z-2246-2012 · Initiated June 27, 2012

    Recall

    Recall Number
    Z-2246-2012
    Event Number
    61671
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    ILK
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    June 27, 2012
    Posted
    August 22, 2012
    Terminated
    December 30, 2013
    Address
    3800 East Centre Ave., Portage, MI, 49002

    Description

    Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

    Reason

    Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.

    Action

    Stryker sent a Urgent Medical Device Recall notice dated June 18, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to " Return the enclosed post card to confirm receipt of this notification. " Locate the chairs listed in this notice. " Call 269-389-6750 to arrange shipment of the chairs to Stryker Medical. " If you have loaned or sold any of the chairs listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location. " If you have disposed of any of the affected chairs and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. We apologize for any disruption that this advisory notice may cause. We strive to make products that meet our customer expectations for quality and durability. For further questions please call (269) 389-6927

    Distribution

    Worldwide Distribution -- USA (nationwide) including the states of AK, AL, AZ, CA, FL, ID, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OR, PA, TN, TX, UT, UT, VA, WA, WI, and WV, and the country of Canada.

    Quantity

    159 units