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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Echelon Oval MRI system

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 Class 2 Device Recall Hitachi Echelon Oval MRI systemsee related information
Date Initiated by FirmAugust 18, 2014
Date PostedSeptember 02, 2014
Recall Status1 Terminated 3 on September 14, 2015
Recall NumberZ-2564-2014
Recall Event ID 68758
510(K)NumberK113145 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductHitachi 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.
Code Information Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information ContactDouglas Thistlethwaite
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
FDA Determined
Cause 2		Device Design
ActionLetters will be sent to customers. Hatachi Serivce will be sent to each site to exchange the Gradient Coil Assembly.
Quantity in Commerce39 systems
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LNH
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