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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi HI VISION 6500

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  Class 2 Device Recall Hitachi HI VISION 6500 see related information
Date Initiated by Firm May 07, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 01, 2008
Recall Number Z-1005-04
Recall Event ID 29160
510(K)Number K013723  
Product Classification Transducer, Ultrasonic, Diagnostic - Product Code ITX
Product Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
Code Information Serial Numbers: SE15704205, SE16773210, and SE16935305.
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		 Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment.
FDA Determined
Cause 2		 Other
Action The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04.
Quantity in Commerce 3 units
Distribution The devices were shipped to consignees in OH, PA, WI.
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 = ITX and Original Applicant = HITACHI MEDICAL CORP.
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