FDA-Device2023-06-07Class II
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Elekta, Inc.
Hazard
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Sold states
Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.
Affected count
46 units
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1665-2023Don't want to check this manually?
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