BEUDAMED
    FDA Recall Terminated

    19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

    Recall: Z-2100-2010 · Initiated June 30, 2010

    Recall

    Recall Number
    Z-2100-2010
    Event Number
    56158
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2010
    Posted
    July 26, 2010
    Terminated
    April 28, 2011
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

    Reason

    Monitor fell from the mounting bracket used to support the monitor.

    Action

    The firm, AGFA Healthcare sent an 'URGENT SAFETY NOTICE" dated June 30, 2010, via FED-EX to customers. The letter describes product, problem and actions to be taken by the firm and customers. AGFA will provide a safety check to the customers facility, have a service representative visit , in the near future, their site to inspect the monitor/s and attach a warning label on each monitor checked for preventative action. The customers are ask to distribute the information within their facility to all individuals who need to be aware, to complete the attached URGENT SAFETY NOTICE FEEDBACK FORM as soon as possible and return via fax at 864-421-1664. If you have any questions about this matter, please feel free to contact me via email at [email protected] or call me at 864-421-1754.

    Distribution

    Worldwide distribution: USA and countries of Puerto Rico and Canada.

    Quantity

    805 units