Company: Varian Medical Systems, Date of Enforcement Report:8/2/2006 Class:lI PRODUCT a) Gamma Win software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus radionuclide applicator system, for radiation therapy, Recall # Z-1268-06; b) Gamma Win software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus 3/24 radionuclide applicator system,...Read More

Company: SCC Soft Computer, Date of Enforcement Report:8/2/2006 Class:lI PRODUCT SoftPath ASXII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinical documentation and data processing, Recall # Z-1243-06 REASON Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a...Read More

Company: Radiometer America, Inc., Date of Enforcement Report:8/2/2006 Class:lI PRODUCT Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic, Model 914-317 Radiance Basic Kit, Recall # Z-1262-06 REASON Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the...Read More

Company: bioMerieux, Inc, Date of Enforcement Report:8/2/2006 Class:lI PRODUCT a) Hamilton brand RAPHAEL Ventilator (Software Version 2.2x), Recall # Z-1249-06; b) Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS), Recall # Z-1250-06; c) Hamilton brand RAPHAEL Color Ventilator (Software Version 2.2xC, 2.2xCU), Recall # Z-1251-06 REASON Alarm Failure — Following an oxygen cell calibration, the...Read More

Company: Beckman Coulter, Inc Date of Enforcement Report:8/2/2006 Class:lI PRODUCT Beckman Coulter Cytomics FC 500 Flow Cytometry System, Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100V), 6605628 (TN; 5CLR, FC500 (120V), 6605629 (TN; 5 CLR, FC500 (220V), 6605630 (TN; 5 CLR, FC500 (240V) with CXP Software Versions 2.0 and 2.1,...Read More

Company: AGFA Corp., Date of Enforcement Report:8/2/2006 Class:lIl PRODUCT IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images, Recall # Z-1256-06 REASON Possible corrupted image appearing after System Start. CODE All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08...Read More