BEUDAMED
    FDA Enforcement Class II Terminated

    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.

    Recall: Z-1836-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1836-2014
    Event ID
    67715
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Claymount Assembli
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    March 15, 2014
    Classification Date
    June 30, 2014
    Termination Date
    October 18, 2018
    Address
    Anholtseweg 44, Dinxperlo, N/A, Netherlands

    Description

    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.

    Reason

    Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases.

    Code Info

    *** US Devices Only *** 1) Part ID: 17360; Serial Numbers: WO186722/E-1 , WO196470/E-1 , WO198534/E-1. 2) Part ID: 17361; Serial Numbers: WO186723/E-1. 3) Part ID: 17362; Serial Numbers: WO186724/E-1 , WO196360/E-1 , WO198545/E-2. 4) Part ID: 18476; Serial Numbers: WO196188/E-1 , WO196188/E-2 , WO196189/E-2. 5) Part ID: 18477; Serial Numbers: WO198547/E-1. 6) Part ID: 18479; Serial Numbers: WO198552/E-1.

    Distribution

    Worldwide Distribution - USA including NC, OH, CO, CA, NJ, IL, OH, PA, FL and Internationally to Canada, China, France, Italy, Netherlands, South Africa, Switzerland, Turkey, and United Kingdom.

    Quantity

    12 devices