FDA-Device2014-09-10Class II
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
Hitachi Medical Systems America Inc
Hazard
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Sold states
Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.
Affected count
39 systems
Manufactured in
1959 Summit Commerce Park, Twinsburg, OH, United States
Products
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2564-2014Don't want to check this manually?
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