BEUDAMED
    FDA Recall Terminated

    Lorad M-IV Mammography System

    Recall: Z-0148-04 · Initiated January 14, 2004

    Recall

    Recall Number
    Z-0148-04
    Event Number
    29764
    Firm
    Lorad, A Division of Hologic
    FEI Number
    1220984
    Product Code
    IZH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 14, 2004
    Posted
    August 11, 2004
    Terminated
    September 15, 2004
    Address
    36 Apple Ridge Rd, Danbury, CT, 06810-7301

    Description

    Lorad M-IV Mammography System

    Reason

    System failed to meet the mA's accuracy specfications at low mA's values

    Action

    Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling.

    Distribution

    Nationwide