Company: Focus Diagnostics IncDate of Enforcement Report:6/25/2014 Class lI: PRODUCT Simplexa” Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa” Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and...Read More

Company: Nihon Kohden America IncDate of Enforcement Report:6/25/2014 Class lI: PRODUCT CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients. Recall Number Z-1979-2014 REASON Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting...Read More

Company:Baxter Healthcare Corp.Date of Enforcement Report: 7/9/2014 Class lI: PRODUCT EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/9/2014 Class lI: PRODUCT ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. Recall Number Z-1962-2014 REASON There is a potential measurement error with the Auto-Stats (auto statistics) measurement...Read More