FDA-Device2023-06-14Class II
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Elekta, Inc.
Hazard
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Sold states
US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
Affected count
18 devices
Manufactured in
400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States
Products
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1675-2023Don't want to check this manually?
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