Company: Varian Oncology Date of Enforcement Report 8/6/2008 Class:ll PRODUCT High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator, Recall # Z-1459-2008 REASON Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration...Read More

Company: Sunquest Information Systems, Inc., Date of Enforcement Report 8/6/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor Modules v5.2, Distributed with Sunquest Laboratory v5.3 and v5.4. and Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta), Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta), Recall # B-1137-08...Read More

This SoftwareCPR.com newsletter lists items added to the web site since March 21,2008 and as of August 6, 2008 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the...Read More

Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 7/23/2008 Class:ll PRODUCT GE Healthcare Centricity Perinatal (formerly QS) System – PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit, Recall # Z-2037-2008 REASON Patient information mix-up: When...Read More

Company: Biotronik, Inc Date of Enforcement Report 8/6/2008 Class:lll PRODUCT Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with...Read More