Company: ThomoTherapy Inc. Date of Enforcement Report 1/14/2009 Class:ll PRODUCT ThomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy, Recall # Z-0339-2009 REASON Treatment plans involving very small structures (volumeRead More

Company: Hitachi Medical Systems America IncDate 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...Read More

Company: Beckman Coulter Inc Date of Enforcement Report 1/14/2009 Class:ll PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2, Recall # Z-0455-2009 REASON Software error: The CXP User documentation does not adequately characterize the use of the Live Gate feature. RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter Inc., Brea, CA,...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 1/14/2009 Class:ll PRODUCT CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System, Recall # Z-0647-2009 REASON Indicated orientation does not match actual orientation of the patient.. RECALLING FIRM/MANUFACTURER Recalling...Read More