BEUDAMED
    FDA Enforcement Class II Terminated

    Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed

    Recall: Z-0274-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0274-2016
    Event ID
    72423
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    October 7, 2015
    Classification Date
    November 13, 2015
    Termination Date
    February 10, 2017
    Address
    1069 State Road 46 E, N/A, Batesville, IN, 47006-7520, United States

    Description

    Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed

    Reason

    Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.

    Code Info

    Product # P3930A; Dates of Manufacture 5-DEC-2007 to 14-SEP-2015; Serial numbers from I325AR0038 thru Q257AR2299

    Distribution

    Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ. CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV., and to the countries of : Canada and France.

    Quantity

    12251 units