BEUDAMED
    FDA Recall Terminated

    CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).

    Recall: Z-0219-2007 · Initiated September 1, 2006

    Recall

    Recall Number
    Z-0219-2007
    Event Number
    36635
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    MBQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2006
    Posted
    November 28, 2006
    Terminated
    April 24, 2008
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).

    Reason

    Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.

    Action

    A Service Bulletin to address the issues was created on 09/01/2006. Customers were notified of the plans to upgrade via telephone and email on 10/13/2006.

    Distribution

    Nationwide

    Quantity

    178 units