Company: Philips Medical SystemsDate of Enforcement Report 7/22/2009 Class:ll PRODUCT TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different...Read More

Company: Gendex Dental SystemsDate of Enforcement Report 7/22/2009 Class:ll PRODUCT Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. Recall # Z-1548-2009 REASON There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software...Read More

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 7/22/2009 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and...Read More