BEUDAMED
    FDA Recall Terminated

    AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

    Recall: Z-0270-2013 · Initiated February 2, 2011

    Recall

    Recall Number
    Z-0270-2013
    Event Number
    63083
    Firm
    Primus Medical LLC
    FEI Number
    3007538326
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    February 2, 2011
    Posted
    November 8, 2012
    Terminated
    May 14, 2014
    Address
    8401 Southern Blvd, Boardman, OH, 44512-6709

    Description

    AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

    Reason

    The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse.

    Action

    The firm, Primus Medical LLC, sent an "Important Notification Relating to Primus Medical Product TL500" letter dated March 29, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to replace the "Retaining washers & Clevis Pins" with the "Clevis Pins & Bow Tie Cotter Pins" in the TL500-001 Service Pack provided with the letter in order to avoid any potential failure and/or bed collapse and to return the" Retaining washers & Clevis Pins" after the replacement procedure is performed. If you have any questions, or need assistance in performing the replacement, call 330-965-9681.

    Distribution

    Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.

    Quantity

    342 Beds