BEUDAMED
    FDA Recall Terminated

    ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).

    Recall: Z-3258-2011 · Initiated April 4, 2011

    Recall

    Recall Number
    Z-3258-2011
    Event Number
    59825
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    OAB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 4, 2011
    Posted
    September 23, 2011
    Terminated
    January 29, 2016
    Address
    603 Queensbury Avenue, Queensbury, NY, 12804

    Description

    ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).

    Reason

    Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture.

    Action

    AngioDynamics, Inc. sent a "NOTIFICATION OF MEDICAL DEVICE CORRECTION" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain,

    Quantity

    21 units