Hitachi Medical Systems America Inc Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Serial Numbers: SE15704205, SE16773210, and SE16935305.
Products Sold
Serial Numbers: SE15704205, SE16773210, and SE16935305.
Hitachi Medical Systems America Inc is recalling Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04- due to 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 tre. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, OH, PA, WI
Page updated: Jan 10, 2026