BEUDAMED
    FDA Recall Terminated

    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

    Recall: Z-2176-2014 · Initiated May 13, 2014

    Recall

    Recall Number
    Z-2176-2014
    Event Number
    68798
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 13, 2014
    Posted
    August 10, 2014
    Terminated
    August 13, 2014
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

    Reason

    Unit was mislabeled with a factory label showing 32 KW output power.

    Action

    Only one customer was affected no customer letter was issued field correction was conducted..

    Distribution

    US in the state of WV

    Quantity

    1