Company:Philips Healthcare Inc. Date of Enforcement Report 7/6/2011 Class ll: PRODUCT Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of...Read More

Company:Lockheed-Martin Aculight Date of Enforcement Report 7/6/2011 Class ll: PRODUCT Lockheed Martin Aculight Capella-r 1850 Laser. The Capella Laser is intended for use in user-defined scientific applications and non-human-use research on infrared nerve stimulation. Recall # Z-2069-2011 REASON It has been determined that there are certain software driven operating sequences involving off-on cycling of the...Read More

Company:AGFA Corp Date of Enforcement Report 7/6/2011 Class ll: PRODUCT IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into...Read More

Company:International Technidyne Corp. Date of Enforcement Report 7/6/2011 Class ll: PRODUCT a) AVOXimeter 1000, b) AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use in the cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/6/2011 Class ll: PRODUCT ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; and syngo RT Therapist Connect/MOSAIQ OIS Part number 08168754. The ONCOR and PRIMUS may be...Read More

Company:AGFA Copr.Date of Enforcement Report 7/6/2011 Class ll: PRODUCT NX is the radiographer’s image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for...Read More