FDA-Device2020-07-08Class II
Elekta Unity, Image-Guided Radiation Therapy System
Elekta, Inc.
Hazard
There have been reports of excessive heating in the MRL Gradient Connection Module.
Sold states
Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.
Affected count
21 devices
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
Elekta Unity, Image-Guided Radiation Therapy System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2473-2020Don't want to check this manually?
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