BEUDAMED
    FDA Enforcement Class II Terminated

    AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.

    Recall: Z-1675-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1675-2013
    Event ID
    65439
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics, INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2013
    Initiation Date
    June 11, 2013
    Classification Date
    July 10, 2013
    Termination Date
    June 12, 2015
    Address
    1 Horizon Way, N/A, Manchester, GA, 31816-1749, United States

    Description

    AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.

    Reason

    The RITA Main Cable product contains the incorrect Instructions for Use.

    Code Info

    Catalog #700-101892, Lot number: 30.12

    Distribution

    Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.

    Quantity

    13 units