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Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation
Recalled October 6, 2021 · FDA recall Z-2563-2021 · Elekta
Hazard
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set. · FDA Class II
Units
214 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.
Description
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Product
Elekta Monaco - Product Usage: 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 →