BEUDAMED
    FDA Recall Terminated

    DX-D600 - DXD Imaging Package

    Recall: Z-1738-2017 · Initiated May 2, 2016

    Recall

    Recall Number
    Z-1738-2017
    Event Number
    76840
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 2, 2016
    Posted
    April 5, 2017
    Terminated
    April 10, 2017
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    DX-D600 - DXD Imaging Package

    Reason

    One of the dent markers from the DX-D600 dropped down from the overhead rail.

    Action

    On May 2, 2016, an "URGENT FIELD SAFETY NOTICE" letter was either emailed or sent via FedEx to the US and Canadian consignees. The notice included an acknowledgment to be sent back. The letter described background information and actions to be taken.

    Distribution

    AL, CA, DC, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, NV, NJ, NM, NY, OH, OK, OR, SC, TN, TX, VA, and Canada

    Quantity

    81 units