Company: Smiths Medical ASD, Inc. Date of Enforcement Report 8/11//2010 Class ll: PRODUCT Medfusion Syringe Infusion Pumps, Models 3010 and 3010a with Software Versions 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Recall # Z-2121-2010 REASON Smiths...Read More

Company: GE Healthcare It. Date of Enforcement Report 8/11//2010 Class ll: PRODUCT 1) GE Centricity PACS-IW software. Device that receives stores and communicates medical images and data from various imaging sources. Recall # Z-1402-201; 2)GE Centricity Web Diagnostic (WebDX) software; Device that receives stores and communicates medical images and data from various imaging sources. Recall...Read More