BEUDAMED
    FDA Recall Terminated

    Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

    Recall: Z-0867-2013 · Initiated January 28, 2013

    Recall

    Recall Number
    Z-0867-2013
    Event Number
    64319
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 28, 2013
    Posted
    February 20, 2013
    Terminated
    April 4, 2014
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

    Reason

    The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.

    Action

    Varian Medical Systems, Inc. Oncology Systems sent an Urgent Medical Device Correction Letter dated January 30, 2013 to all affected customers. The Letter identified the affected product, problem and actions to be taken. Varian Medical Systems is developing a technical correction for this issue, Its customers will be contacted by a Varian Customer Service representatives when this correction is available to schedule its installation. The letter provides customers with help desk contact information.

    Distribution

    Worldwide Distribution - USA Nationwide

    Quantity

    1168 units