Company: Varian Medical Systems, Inc.Date of Enforcement Report 8/31/11 Class ll: PRODUCT Eclipse Treatment Planning System; Radiotherapy treatment for patients with malignant and benign diseases. Model No. H48. Recall # Z-2788-2011 REASON A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used...Read More

Company: Becton Dickinson & Co..Date of Enforcement Report 8/31/11 Class ll: PRODUCT BD BACTEC(tm) MGIT ™ System Software, Catalog 445922. Product Usage: The BACTEC(tm) MGIT ™ System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection of mycobacteria from clinical specimens. In addition, an Antimicrobial/Drug Susceptibility Testing (AST or...Read More

Company: Philips Healthcare Inc.Date of Enforcement Report 8/31/11 Class ll: PRODUCT Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20- High resolution fixed-x ray Allura Xper FD20/10 Allura Xper FD20/20 Allura CV20 The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended...Read More