Class 2 Device Recall Altaire

• Date Initiated by Firm: April 11, 2005
• Date Posted: May 03, 2005
• Recall Status: Terminated on April 12, 2012
• Recall Number: Z-0797-05
• Recall Event ID: 31768
• 510(K)Number: K022390 K002420
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Altaire, Magnetic Resonance Imaging Device.
• Code Information: Serial numbers: L001 to L212
• 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 electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
• FDA Determined Cause: Other
• Action: The firm sent a recall/field correction letter, dated 4/11/05, to direct accounts.
• Quantity in Commerce: 212 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 and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.