BEUDAMED
    FDA Enforcement Class II Terminated

    AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.

    Recall: Z-0067-2015 · Reported October 22, 2014

    Enforcement

    Recall Number
    Z-0067-2015
    Event ID
    69357
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Primus Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2014
    Initiation Date
    September 15, 2014
    Classification Date
    October 14, 2014
    Termination Date
    August 10, 2017
    Address
    8401 Southern Blvd, N/A, Boardman, OH, 44512-6709, United States

    Description

    AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.

    Reason

    Firm received several complaints that the head deck actuator bracket had separated from the bed frame.

    Code Info

    PCB900 manufactured between 09/13/2010 and 05/22/2012

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, GA, IL, IN, KS, KY, MA, MN,MS, NC, NM, NV, NY, OH, PA, TN, TX, and VA, and the country of Canada.

    Quantity

    1726