Company: Hitachi Medical Systems America Inc
Date of Enforcement Report: 6/16/04
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM Service Pack 1 and EZU-FC5W. Recall # Z-1005-04.
Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in misdiagnosis and delay in treatment.
Serial Numbers: SE15704205, SE16773210, and SE16935305.
Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on May 7, 2004 and May 25, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
OH, PA, and WI.