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Elekta, Inc. recalls Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. El
Recalled June 7, 2023 · FDA recall Z-1665-2023 · Elekta
Hazard
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 · FDA Class II
Units
46 units
Sold at
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.
Description
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Product
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →