Company: GE Healthcare ITDate of Enforcement Report: 7/3/2013 Class ll: PRODUCT The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 7/3/2013 Class ll: PRODUCT CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 7/3/2013 Class ll: PRODUCT Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission. Recall Number Z-1588-2013 REASON If the operator selects a patient name...Read More