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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 system see related information
Date Initiated by Firm August 18, 2014
Date Posted September 02, 2014
Recall Status1 Terminated 3 on September 14, 2015
Recall Number Z-2564-2014
Recall Event ID 68758
510(K)Number K113145  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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.
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 Contact Douglas 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
Action Letters will be sent to customers. Hatachi Serivce will be sent to each site to exchange the Gradient Coil Assembly.
Quantity in Commerce 39 systems
Distribution 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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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