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.
FDA Recall Z-2564-2014 · Posted 2014-09-02
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Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2014-08-18
Date Terminated2015-09-14
Product Quantity39 systems
Reason for Recall
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Firm Action
Letters will be sent to customers. Hatachi Serivce will be sent to each site to exchange the Gradient Coil Assembly.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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