FDA-Device2021-11-03Class II
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Elekta, Inc.
Hazard
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Sold states
Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam
Affected count
1072 devices
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0182-2022Don't want to check this manually?
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