Company: Hitachi Medical Corporation
Date of Enforcement Report 7/30/2008
Class:lll

PRODUCT
EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information, Recall # Z-1571-2008

REASON
Miscalculation reading. A software error in the firm’s EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of the left ICA/CCA ratio when using the Carotid Calculation package for patient scans..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on February 25, 2008.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
20 units

DISTRIBUTION
Nationwide