Company:Hitachi Medical Systems America Inc., .,
Date of Enforcement Report:6/14/2006
Class:lI
PRODUCT
Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT). Recall # Z-1079-06
REASON
The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized
CODE
CXR46201-46214 PC46002-46011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on February 21, 2006.
Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16 devices
DISTRIBUTION
Nationwide
