BEUDAMED
    FDA Recall Terminated

    Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    Recall: Z-0112-2016 · Initiated September 15, 2015

    Recall

    Recall Number
    Z-0112-2016
    Event Number
    72221
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 15, 2015
    Posted
    October 7, 2015
    Terminated
    April 4, 2017
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    Reason

    Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

    Action

    The firm issued an URGENT IMPORTANT FIELD SAFETY NOTICE on 09/15/2015. The letter identified the affected device, as well as the reason for the recall, and clinical impact. Customers were informed that both issues would be resolved in Monaco Patch Release 5.10.01. The attached acknowledgement form should be completed, signed, and returned to a local Elekta Office or representative within 30 days. Questions regarding the notice should be directed to a local Elekta office.

    Distribution

    Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.

    Quantity

    154 units