Company: Hitachi Medical Systems America Inc.,
Date of Enforcement Report:6/14/2006
Class:lI
PRODUCT
Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT), Recall # Z-1078-06
REASON
The device has a software anomaly which affects the system’s ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them.
CODE
Serial Number: CXR46201-46213 PC 46002-36011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on February 21, 2006.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
15 devices
DISTRIBUTION
Nationwide
