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

• Date Initiated by Firm: April 25, 2006
• Date Posted: June 14, 2006
• Recall Status: Terminated 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: 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