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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Altair, Airis Elite, AIRIS II MRI System see related information
Date Initiated by Firm February 21, 2006
Date Posted May 31, 2006
Recall Status1 Terminated 3 on February 16, 2012
Recall Number Z-0910-06
Recall Event ID 35087
510(K)Number K022390  k002420  K974212  K032232  
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 2		 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 and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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