Company:superDimension, Inc Date of Enforcement Report 7/18/12 Class ll: PRODUCT superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a...Read More

Company:Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 7/18/12 Class ll: PRODUCT Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 7/18/12 Class ll: PRODUCT Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in...Read More

Company:Philips Medical Systems Date of Enforcement Report 7/18/12 Class ll: PRODUCT IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation. Z-1987-2012...Read More

Company:Philips Medical Systems Date of Enforcement Report 7/18/12 Class ll: PRODUCT Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Recall Number Z-1988-2012 REASON Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances....Read More

Company:GE OEC Medical Systems, Inc. Date of Enforcement Report 7/18/12 Class ll: PRODUCT InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 7/18/12 Class ll: PRODUCT GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission...Read More