Company:Varian Medical Systems, Inc.Date of Enforcement Report 5/18/2011 Class ll: PRODUCT The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup...Read More

Company:Beckman Coulter Inc.Date of Enforcement Report 5/18/2011 Class ll: PRODUCT 1) UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured A25288, DxI 800 with spot B A71456, DxI 800 Reconditioned A25285 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of...Read More

Company:Quest Medical, Inc.Date of Enforcement Report 5/18/2011 Class lll: PRODUCT Quest MPS and MPS 2 Consoles, Quest Medical, Inc., an Atrion Company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS...Read More

Company:Philips Healthcare Inc.Date of Enforcement Report 5/18/2011 Class ll: PRODUCT Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link. Recall # Z-2175-2011 REASON Edits to an order can result in unintended scheduled interventions...Read More

Company:Bio-Rad, Laboratories IncDate of Enforcement Report 5/18/2011 Class ll: PRODUCT Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. a) Catalog Numbers: 270-2415 and b) 270-2417; The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in...Read More

Company:Bio-Rad Laboratories Inc.Date of Enforcement Report 5/18/2011 Class lll: PRODUCT Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative...Read More