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U.S. Department of Health and Human Services

Class 2 Device Recall MRP7000 AIRIS magnetic resonance imaging devices

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  Class 2 Device Recall MRP7000 AIRIS magnetic resonance imaging devices see related information
Date Initiated by Firm March 17, 2006
Date Posted June 10, 2006
Recall Status1 Terminated 3 on November 13, 2008
Recall Number Z-1105-06
Recall Event ID 35103
510(K)Number K911667  K945155  
Product Classification MRI magnetic resonance imaging devices - Product Code LNH
Product MRP-7000, AIRIS Magnetic Resonance Imaging Systems
Code Information Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact
330-425-1313
Manufacturer Reason
for Recall		 Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.
FDA Determined
Cause 2		 Other
Action On 3/17/2006, the firm began conducting a survey of all afftected customer sites in order to determine if corrected software has been installed on the unit(s) at each customer location. If the corrected software has not been installed, the firm''s Field Service Engineers will install software upgrades as necessary.
Quantity in Commerce 283
Distribution Nationwide-The devices were distributed to consignees located througout the United States.
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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