BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1233-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1233-2023
    Event ID
    91773
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 15, 2023
    Initiation Date
    February 28, 2023
    Classification Date
    March 7, 2023
    Address
    1450 Beale St Ste 205, Saint Charles, MO, 63303, United States

    Description

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

    Reason

    Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

    Code Info

    Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03

    Distribution

    Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestinian Territory, Occupied, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Zimbabwe.

    Quantity

    2,020 units