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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi AIRIS II Magnetic Resonance Imaging Device

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 Class 2 Device Recall Hitachi AIRIS II Magnetic Resonance Imaging Devicesee related information
Date Initiated by FirmJune 30, 2005
Date PostedJune 14, 2005
Recall Status1 Terminated 3 on September 14, 2010
Recall NumberZ-0889-05
Recall Event ID 32211
510(K)NumberK001334 K974212 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
ProductHitachi AIRIS II Magnetic Resonance Imaging Device
Code Information C002 thru C795, C907, and C910.
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information ContactDoug Thistlethwaite
330-425-1313
Manufacturer Reason
for Recall		Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
FDA Determined
Cause 2		Other
ActionThe recalling firm is sending recall letters to all consignees.
Quantity in Commerce771 devices
DistributionThe product was distributed throughout the United States and to one consignee located in both Wales and London.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
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