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Class 2 Device Recall Hitachi Echelon Oval MRI system |
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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
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Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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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
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For Additional Information Contact |
Douglas Thistlethwaite 330-425-1313 Ext. 3720
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Manufacturer Reason for Recall |
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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