BEUDAMED
    FDA Recall 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 · Initiated June 11, 2013

    Recall

    Recall Number
    Z-1675-2013
    Event Number
    65439
    Firm
    Angiodynamics, INC
    FEI Number
    3017892510
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 11, 2013
    Posted
    July 10, 2013
    Terminated
    June 12, 2015
    Address
    1 Horizon Way, Manchester, GA, 31816-1749

    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.

    Action

    Consignees were notified via certified mail on 06/11/2013 with an "Urgent Medical Device Field Safety Correction" notification. This included the correct Instructions for Use and the recommended actions.

    Distribution

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

    Quantity

    13 units