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Elekta, Inc. recalls Elekta Unity, Image-Guided Radiation Therapy System
Recalled July 8, 2020 · FDA recall Z-2473-2020 · Elekta
Hazard
There have been reports of excessive heating in the MRL Gradient Connection Module. · FDA Class II
Units
21 devices
Sold at
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.
Description
There have been reports of excessive heating in the MRL Gradient Connection Module.
Product
Elekta Unity, Image-Guided Radiation Therapy System
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →