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U.S. Department of Health and Human Services

Class 2 Device Recall AIRIS II, Altaire Magnetic Resonance Imaging Devices

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  Class 2 Device Recall AIRIS II, Altaire Magnetic Resonance Imaging Devices see related information
Date Initiated by Firm April 28, 2006
Date Posted June 10, 2006
Recall Status1 Terminated 3 on November 24, 2008
Recall Number Z-1104-06
Recall Event ID 35100
510(K)Number K974212  K002420  
Product Classification Magnetic Resonance Imaging MRI - Product Code LNH
Product AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Code Information Serial Numbers: Altaire - L217, L219, L221, L224 and L225; AIRIS II - C686-C688* [*The AIRIS units remained in Hitachi's inventory and were not distributed].
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		 Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.
FDA Determined
Cause 2		 Other
Action The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006.
Quantity in Commerce 5
Distribution The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
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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