16
Jun
2004

Hitachi Medical Systems America Inc Class II

0

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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