BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0067-2015 · Initiated September 15, 2014

    Recall

    Recall Number
    Z-0067-2015
    Event Number
    69357
    Firm
    Primus Medical LLC
    FEI Number
    3007538326
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 15, 2014
    Posted
    October 15, 2014
    Terminated
    August 10, 2017
    Address
    8401 Southern Blvd, Boardman, OH, 44512-6709

    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.

    Action

    Primus Medical will send a letter notifying all customers with PCB900 beds at their facility of the potential head bracket separation.

    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