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Hitachi Medical Systems America Inc recalls Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the ph
Recalled September 10, 2014 · FDA recall Z-2564-2014 · Hitachi Medical Systems America
Hazard
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard. · FDA Class II
Units
39 systems
Sold at
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.
Description
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Product
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.
Manufacturer(s)
Hitachi Medical Systems America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →