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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System

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  Class 2 Device Recall Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System see related information
Date Initiated by Firm April 25, 2006
Date Posted June 14, 2006
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-1115-06
Recall Event ID 35107
510(K)Number K001334  K974212  
Product Classification MRI - Product Code LNH
Product Hitachi AIRIS II MRI System
Code Information Serial Numbers: C322- to C546; and C746 to C772
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Douglas J. Thistlethwaite
330-425-1313
Manufacturer Reason
for Recall		 Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.
FDA Determined
Cause 2		 Other
Action The recalling firm plans to inspect the transformer connections for damaged wiring and check the connections for tightness and tighten as necessary. The inspections and possible corrections began on 4/25/2006 and are in the process of being conducted by the firm''s Field Service Engineers. The firm anticipates trhat these actions will be completed by 6/25/2006.
Quantity in Commerce 248
Distribution The devices were distributed to consignees located throughout the United States.
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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