Class 2 Device Recall Altaire

• Date Initiated by Firm: November 18, 2004
• Date Posted: May 17, 2005
• Recall Status: Terminated on January 04, 2008
• Recall Number: Z-0846-05
• Recall Event ID: 31772
• 510(K)Number: K002420 K022390
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Altaire, Magnetic Resonance Imaging Device.
• Code Information: Serial numbers: L001 to L191.
• Recalling Firm/ Manufacturer: Hitachi Medical Systems America Inc; 1995 Summit Commerce Park; Twinsburg OH 44087-2371
• For Additional Information Contact: Doug Thistlethwaite; 330-425-1313
• Manufacturer Reason for Recall: The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.
• FDA Determined Cause: Other
• Action: The firm implemented site inspections of customers beginning on 11/19/04 which have been completed. Customers that had the suspect component had it replaced.
• Quantity in Commerce: 189 devices
• Distribution: Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
• 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