Philips iSite PACS 3.6 education provides quick tips to compliment powerful enhanced clinical workflow training. Magic Clothes Eraser V 3.11. The free resources on this page will help you get started using your iSite PACS 3.6 software. Visit this page often to view additional basic and advanced software trainings as they become available. This material. ISite Radiology Proper Usage Statement. Who Should Read This Manual. This manual is intended for clinical users of the Philips iSite Radiology product. Anybody in a healthcare organization who intends to use this product should read this manual carefully. We also recommend that you receive basic product-use training.
Class 2 Device Recall iSite PACS Date Initiated by Firm January 29, 2008 Date Posting Updated August 16, 2008 Recall Status Terminated on September 25, 2008 Recall Number Z-1443-2008 Recall Event ID 510(K)Number Product Classification - Product Code Product Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 220.127.116.11 - Radiology Image management system. Code Information Version number 18.104.22.168 Recalling Firm/ Manufacturer Philips Healthcare Informatics, Inc. 4100 E 3rd Ave Ste 101 Foster City CA For Additional Information Contact 650-293-2624 Manufacturer Reason for Recall When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool. FDA Determined Cause Software design Action The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem.