Company: Hitachi Medical Systems America Inc
Date of Enforcement Report 1/14/2009
Class:ll
PRODUCT
Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications, Recall # Z-0608-2009
REASON
Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal). .
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letters on November 5, 2008.
Manufacturer: Hitachi Medical Corp., Tokyo, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide
