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

Recalled March 15, 2023 · FDA recall Z-1233-2023 · Elekta

Hazard

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

Units

2,020 units

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Elekta Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →