Company: Dade Behring, Inc Date of Enforcement Report 1/21/2009 Class:ll PRODUCT Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use. Recall # Z-0581-2009 REASON Error...Read More

Company: Beckman Coulter Inc Date of Enforcement Report 1/21/2009 Class:ll PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one...Read More

Company: Accuray, Inc. Date of Enforcement Report 1/28/2009 Class:ll PRODUCT Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when...Read More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 1/21/2009 Class:ll PRODUCT Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC. Recall # Recall # Z-0870-2009 REASON Software error: There are two potential safety...Read More