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
