Company: Hitachi Medical Systems America Inc.
Date of Enforcement Report:10/18/2006
Class:ll
PRODUCT
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007
REASON
Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.
CODE
AIRIS – Serial Number Range: A001, AG001-AG039, A901; MRP-7000 – Serial Number Range: 7001- 7154..
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on August 16, 2006. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
348 systems
DISTRIBUTION
Nationwide and PR
