Company:Mindray DS USA, Inc. d.b.a. Mindray North America Date of Enforcement Report 9/5/12 Class ll: PRODUCT V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the...Read More

Company:Toshiba American Medical Systems Inc. Date of Enforcement Report 9/5/12 Class ll: PRODUCT Whole Body X–ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation. Z-2282-2012 REASON 1. It has been found that in raw data processing for...Read More

Company:Toshiba American Medical Systems Inc. Date of Enforcement Report 9/5/12 Class ll: PRODUCT EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy. Z-2278-2012 REASON The status display in the...Read More

Company:Cisco Systems Date of Enforcement Report 9/5/12 Class ll: PRODUCT Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a...Read More

Company:Sendx Medical Inc Date of Enforcement Report 9/5/12 Class ll: PRODUCT ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) – pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases,...Read More