Company: Varian Medical Systems Inc, Date of Enforcement Report 2/20/2008 Class:ll PRODUCT Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models, Recall # Z-0720-2008 REASON Incorrect Software Validation. The ARC treatment plans containing a Dose Dynamic MLC for IMRT...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 2/20/2008 Class:ll PRODUCT Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Recall # Z-0719-2008 REASON Software error: Error affects all Aspen customer systems using the PAL video standard configuration and has a Perspective PC installed. This can lead to a...Read More

Company:Philips Medical Systems Date of Enforcement Report 2/20/2008 Class:ll PRODUCT Philips Medical Systems — Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5, Recall Z-0676-2008 REASON Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software...Read More