Company:Volcano Corp., Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology. Recall # Z-0168-2011 REASON Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification...Read More

Company: Hospira, Inc.Date of Enforcement Report: 12/8/2010 Class ll: PRODUCT EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5. Recall # Z-0126-2011 REASON The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: Philips Healthcare.Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-0133-2011 REASON Philips Healthcare has decided to recall the Computed Tomography X-Ray System...Read More

Company:Philips Medical Systems Date of Enforcement Report 12/8/2010 Class ll: PRODUCT 1) Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems. Recall # Z-0124-2011;...Read More

Company: CareFusion Corp..Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module. Recall # Z-0492-2011 REASON Issue: PC Unit model 8000, when used with Pump or Syringe modules, may under certain conditions display an incorrect total dose when programmed to deliver...Read More

Company:Instrumentation Laboratory Co.Date of Enforcement Report 12/8/2010 Class ll: PRODUCT 1) ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis...Read More