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U.S. Department of Health and Human Services

Class 2 Device Recall Echelon Magnetic Resonance Imaging Device

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 Class 2 Device Recall Echelon Magnetic Resonance Imaging Devicesee related information
Date Initiated by FirmAugust 14, 2006
Date PostedNovember 04, 2006
Recall Status1 Terminated 3 on September 19, 2012
Recall NumberZ-0152-2007
Recall Event ID 36525
510(K)NumberK052172 
Product Classification Magnetic Resonance Imaging Device (MRI) - Product Code MOS
ProductHitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
Code Information Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.
FEI Number 1528028
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact
330-425-1313
Manufacturer Reason
for Recall		Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
FDA Determined
Cause 2		Other
ActionThe recalling firm issued a Device Correction letter to the clinic customer on 9/15/2006 making them aware of this potential problem and of their completed corrective action on 8/14/2006, by a Service Rep visit.
Quantity in Commerce1 unit
DistributionThe recalled unit was distributed to a single customer.
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 = MOS
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