Hitachi Medical Systems America Inc Class II

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.

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