BEUDAMED
    FDA Recall Terminated

    Radionics Head and Neck Localilizer (HNL), Version B

    Recall: Z-1020-04 · Initiated May 25, 2004

    Recall

    Recall Number
    Z-1020-04
    Event Number
    29219
    Firm
    Radionics, Inc.
    FEI Number
    1000120652
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 25, 2004
    Posted
    July 20, 2004
    Terminated
    February 28, 2005
    Address
    22 Terry Ave, Burlington, MA, 01803-2516

    Description

    Radionics Head and Neck Localilizer (HNL), Version B

    Reason

    Software may provide inaccurate coordinates and cause mistreatment

    Action

    Radionics notified users by telephone and follow-up letters dated 5/25/04 via facsmile. Users are requested not to use the system. A corrected software will be issued.

    Distribution

    Canada, Germany, Greece

    Quantity

    4