30

Sep

2009

Cl Il Hitachi DICOM Ultrasound Scanner

0

Company:Hitachi Medical Systems America Inc., .
Date of Enforcement Report 9/30/2009
Class:ll

PRODUCT
1) EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Recall # Z-2054-2009;

2) EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A. Recall # Z-2055-2009

REASON
The firm’s parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on May 12, 2008.
Manufacturer: Hitachi Medical Corp., Tokyo, Japan. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
16 units

DISTRIBUTION
AR, CA, TX

About the author

Amy Sellers

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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