Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
FDA Recall Z-1005-04 · Posted 2004-07-20
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2004-05-07
Date Terminated2008-11-01
Product Quantity3 units
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.
Firm Action
The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04.
Root Cause
Other
Distribution Pattern
The devices were shipped to consignees in OH, PA, WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.