Company: Hitachi Medical Systems America Inc
Date of Enforcement Report: 6/16/04
Class: II
PRODUCT
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.
REASON
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.
CODE
Serial Numbers: SE15704205, SE16773210, and SE16935305.
RECALLING FIRM/MANUFACTURER
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
3 units.
DISTRIBUTION
OH, PA, and WI.
