BEUDAMED
    FDA Enforcement Class II Terminated

    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

    Recall: Z-0050-2018 · Reported November 1, 2017

    Enforcement

    Recall Number
    Z-0050-2018
    Event ID
    78087
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nucletron BV
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 1, 2017
    Initiation Date
    August 10, 2017
    Classification Date
    October 26, 2017
    Termination Date
    November 20, 2020
    Address
    Waardgelder 1, POBox 930, Veenendaal, N/A, N/A, Netherlands

    Description

    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

    Reason

    Incorrect source step size may occur in the software plans

    Code Info

    Versions 4.5, 4.5.1, and 4.5.2.

    Distribution

    Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam. There was no military/government distribution.

    Quantity

    89 customer sites have the affected software