Company:Hitachi Medical Systems America, Inc.
Date of Enforcement Report:6/7/2006
Class:lI
PRODUCT
Magnetic Resonance Imaging Device, Recall # Z-0910-06
REASON
The device has a software anomaly which causes the operating system to lock up and data to become corrupted during service procedures.
CODE
L001-L223 C002-C765 Hoo2-H733
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visits beginning on February 21, 2006.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,054 units
DISTRIBUTION
Nationwide