BEUDAMED
    FDA Enforcement Class II Terminated

    AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

    Recall: Z-0073-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0073-2022
    Event ID
    88679
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    October 13, 2021
    Initiation Date
    April 24, 2020
    Classification Date
    October 7, 2021
    Termination Date
    September 20, 2022
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619, United States

    Description

    AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

    Reason

    Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.

    Code Info

    lot 5577754

    Distribution

    Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.

    Quantity

    37