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Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Recalled June 14, 2023 · FDA recall Z-1675-2023 · Elekta
Hazard
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems. · FDA Class II
Units
18 devices
Sold at
US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
Description
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Product
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →