BEUDAMED
    FDA Recall Terminated

    Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48; Reference/FSCA Identifier: CP-04931; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases.

    Recall: Z-3022-2011 · Initiated July 7, 2011

    Recall

    Recall Number
    Z-3022-2011
    Event Number
    59394
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 7, 2011
    Posted
    August 15, 2011
    Terminated
    April 4, 2014
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48; Reference/FSCA Identifier: CP-04931; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases.

    Reason

    An anomaly has been identified in the 4D Structure Merge option of certain versions of Varian's Eclipse Treatment Planning System. The treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the MU or calculated dose distribution.

    Action

    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/FIELD SAFETY NOTICE" letter dated July 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to cease using the 4D Structure Merge tool option in the Eclipse until further notice. Additionally, it is recommended that customers ensure that a qualified physician reviews the accuracy and placement of all patient structures used for plan development and evaluation and to conduct standard quality assurance procedures prior to patient treatment. Customers will be contacted by a Customer Service representative when the technical correction for this issue is available. Contact your local Varian Customer Support District or Regional Manager if you have questions regarding this notice.

    Distribution

    Worldwide Distribution