Class 2 Device Recall Altair, Airis Elite, AIRIS II MRI System

• Date Initiated by Firm: February 21, 2006
• Date Posted: May 31, 2006
• Recall Status: Terminated on February 16, 2012
• Recall Number: Z-0910-06
• Recall Event ID: 35087
• 510(K)Number: K002420 K022390 K032232 K974212
• Product Classification: MRI - Product Code LNH
• Product: Magnetic Resonance Imaging Device
• Code Information: L001-L225 - Altaire C001-C693* - AIRIS II C701-C790 - AIRIS II Upgrades H001-H091 - AIRIS Elite H701-H748* - AIRIS Elite Upgrades *The firm informed CIN-DO in their status reports for May, 2006 and again in August, 2007, that duplication was found in the number of system units originally reported to CIN-DO in early 2006. Ten (10) of the AIRIS II System units had been previously upgraded to AIRIS Elite units [System Unit Numbers: C012, C014, C032, C063, C111, C138, C263, C347, and C495] and are these numbers are reflected in the total # of AIRIS Elite System Unit Numbers listed above* **By the same token, *eight (8) AIRIS Elite Upgrades [System ID Numbers: H735, H736, H740, H743, H745, H746, H747 & H748] were reportedly installed well after the corrective action was underway (7/28/06 to 11/24/2006) and were not-subject to corrective action. As a result, the total # of affected system units/customers has been revised to reflect the number reported by the firm [1129] beginning with their May, 2006 status report and continuing through to their final communication to CIN-DO dated 8/21/2007. - clp
• 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: The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
• FDA Determined Cause: Other
• Action: The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06.
• Quantity in Commerce: 1129
• Distribution: Nationwide
• 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