BEUDAMED
    FDA Recall Terminated

    Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups

    Recall: Z-0076-2017 · Initiated September 29, 2016

    Recall

    Recall Number
    Z-0076-2017
    Event Number
    75303
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 29, 2016
    Terminated
    July 16, 2021
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups

    Reason

    When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.

    Action

    Elekta sent an Important Field Safety Notice 382-01-MON-005 was sent to all affected customers on 9/29/2016. The notice informs users of the specific product and version numbers affected by the issue,and any work arounds that can be used to avoid the issue. The notice included an acknowledgment form which is to be returned. For questions regarding this recall call 314-993-0003 or 800-878-4287.

    Distribution

    Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI. Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.

    Quantity

    365