FDA-Device2023-03-15Class II
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Elekta Inc
Hazard
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Sold states
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.
Affected count
2,020 units
Manufactured in
1450 Beale St Ste 205, Saint Charles, MO, United States
Products
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2023Don't want to check this manually?
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