Class 2 Device Recall AIRIS MR System

• Date Initiated by Firm: December 01, 2005
• Date Posted: January 24, 2006
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-0428-06
• Recall Event ID: 34060
• 510(K)Number: K945155
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: The AIRIS MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagital, oblique, and curved cross-sectional images that display the internal structure of the head, body, and extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance and proton density, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
• Code Information: Serial numbers A305 thru A341.
• Recalling Firm/ Manufacturer: Hitachi Medical Systems America Inc; 1959 Summit Commerce Park; Twinsburg OH 44087-2371
• For Additional Information Contact: Doug Thistlethwaite; 330-425-1313
• Manufacturer Reason for Recall: The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
• FDA Determined Cause: Other
• Action: The recalling firm sent a recall/field correction letter, dated 12/1/05 to all consignees.
• Quantity in Commerce: 32 devices
• Distribution: The devices were distributed to FL, WA, IL, TX, NC, NY, OH, CO, LA, NJ, CA, AZ, SC, AR, OK, MN, SD, OR, PA, AL, GA, MD, MS, MO, CT, WI, KY, IN, KS, MA, DE, IA, UT, TN, VA, ID, NE, ND, NV, Puerto Rico, and to St. Thomas, Virgin Islands.
• 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