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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 Device see related information
Date Initiated by Firm August 14, 2006
Date Posted November 04, 2006
Recall Status1 Terminated 3 on September 19, 2012
Recall Number Z-0152-2007
Recall Event ID 36525
510(K)Number K052172  
Product Classification Magnetic Resonance Imaging Device (MRI) - Product Code MOS
Product Hitachi 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.
Recalling Firm/
Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact
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
Action The 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 Commerce 1 unit
Distribution The recalled unit was distributed to a single customer.
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 = MOS and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.