Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/28/2015 Class lI: PRODUCT VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 – in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 – in vitro quantitative, semi-quantitative, and qualitative...Read More

Company:Maquet Medical Systems USADate of Enforcement Report: 1/28/2015 Class lI: PRODUCT TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the cental operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 1/28/2015 Class lI: PRODUCT Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull,...Read More