BEUDAMED
    FDA Recall Terminated

    Agfa Healthcare NX 3.0.8950 Imaging Processing Software

    Recall: Z-2735-2017 · Initiated December 21, 2016

    Recall

    Recall Number
    Z-2735-2017
    Event Number
    77632
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 21, 2016
    Terminated
    July 10, 2019
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Agfa Healthcare NX 3.0.8950 Imaging Processing Software

    Reason

    A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.

    Action

    On December 22, 2016, an URGENT FIELD SAFETY NOTICE letter was sent either by mail or email. The letter included an acknowledgement form to be returned. The letter informed the customer of the problem and actions to be taken.

    Distribution

    AL, AZ, AR, CA, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV and Canada

    Quantity

    221 units