BEUDAMED
    FDA Recall Terminated

    Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.

    Recall: Z-2461-2015 · Initiated May 1, 2015

    Recall

    Recall Number
    Z-2461-2015
    Event Number
    71556
    Firm
    Ferno-Washington Inc
    FEI Number
    1523574
    Product Code
    FPO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 1, 2015
    Posted
    August 25, 2015
    Terminated
    November 6, 2015
    Address
    70 Weil Way, Wilmington, OH, 45177-9371

    Description

    Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.

    Reason

    The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.

    Action

    Ferno's first action of May 1, 2015 was to telephone all customers to alert them to the potential issue and explain our planned inspection. Ferno's Technical Support Manager emailed a copy of the Service Notice and iNX Equipment Evaluation Form to the customers as well.

    Distribution

    Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.

    Quantity

    26 units