BEUDAMED
    FDA Recall Terminated

    High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    Recall: Z-3052-2011 · Initiated June 6, 2011

    Recall

    Recall Number
    Z-3052-2011
    Event Number
    59226
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 6, 2011
    Posted
    August 22, 2011
    Terminated
    December 23, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    Reason

    When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose.

    Action

    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter describes various jaw position recommendations to be followed when planning and treating dynamic fields on the HD120 MLC. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice.

    Distribution

    Worldwide Distribution.

    Quantity

    173***12-20-12 AMENDED TO: 106 units***