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U.S. Department of Health and Human Services

Class 2 Device Recall Hi Vision ultrasound diagnostic scanners

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 Class 2 Device Recall Hi Vision ultrasound diagnostic scannerssee related information
Date Initiated by FirmMay 12, 2008
Date PostedSeptember 09, 2009
Recall Status1 Terminated 3 on July 20, 2011
Recall NumberZ-2054-2009
Recall Event ID 52434
510(K)NumberK013723 
Product Classification Diagnostic ultrasonic transducer - Product Code ITX
ProductEUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.
Code Information The following Serial Numbers for this device were subject to recall/software correction: 17094308, 17094309, 17150307, 17350302, 17094305, 17869402, 18435403, 18435404, 17492302, and 17204305.
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087
For Additional Information Contact
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.
FDA Determined
Cause 2		Software design
ActionHMSA issued a 'DEVICE CORRECTION' notification to their customers on 5/12/2008. The notification describes the potential data transmission problem (potential to archive studies done on different patients into the same patient folder) and the conditions under which this problem can occur. The notification cautions the user/customer to verify all images stored on the PACS (Picture Archiving and Communications System) in order to ensure that they do not contain images from a different patient. The DEVICE CORRECTION letter also states that the firm will be installing updated software on all affected systems beginning in June, 2008, in order to address this issue. It also states that a Hitachi Service Rep. will be contacting each customer and making arrangements to set up a convenient time to come out and perform a software upgrade. Lastly, the letter provides a toll-free telephone # to the firm's 'Customer Service Center: 1-800-800-4925, which the customer can use to obtain additional information, if desired.
Quantity in Commerce10 units
DistributionThe recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.
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 = ITX
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