Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/10/2008 Class:lll PRODUCT syngo MultiModality WorkPlace (MM WP). Software product (Model Number 10140720). The product is intended for use in picture archiving and communications system; Recall # Z-0324-2009 REASON Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected. RECALLING...Read More

Company: Sunquest Laboratory SystemDate of Enforcement Report 12/10/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1 Distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Laboratory Blood Bank and Blood Donor version 6.0.2 Distributed with Sunquest Laboratory 6.3, Recall # B-0149-09 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER...Read More

Company: Viasys Healthcare, Inc/Cardinal Health Inc.Date of Enforcement Report 12/10/2008 Class:lll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1 Distributed with GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can...Read More

Company: GE Healthcare Integrated IT SolutionsDate of Enforcement Report 12/10/2008 Class:lll PRODUCT GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System – Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended...Read More