Company:Ortho-Clinical Diagnostics Date of Enforcement Report 8/112 Class ll: PRODUCT VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. Z-2066-2012 REASON software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/112 Class ll: PRODUCT Siemens syngo.plaza. Radiological image processing system. Z-2078-2012 REASON Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message...Read More

Company:AGFA Corp. Date of Enforcement Report 8/112 Class ll: PRODUCT IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view,...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 8/1/12 Date Recall Initiated: May 25, 2012 Class l: PRODUCT Alaris PC unit, model 8015 with PC unit power supply board P/N TC10005122, manufactured after January 2011. Affected product was distributed from January 1, 2011, to May 31, 2012. The Alaris PC unit, model 8015 is part...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/112 Class ll: PRODUCT ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of...Read More