Company: Hitachi Medical Corporation.
Date of Enforcement Report 8/5/2009
Class:ll
PRODUCT
1) Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less, Recall # Z-1651-2009;
2) Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version 2.11 or less, Recall # Z-1652-2009
REASON
Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on April 14, 2009.
Manufacturer: Hitachi Medical Corporation, Tokyo, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
Nationwide
