Company: Philips Ultrasound, Inc.,Date of Enforcement Report: 7/6/05 Class: II PRODUCT Envisor, M2540 Diagnostic Ultrasound System, Part numbers: 453561193003, SW C.O.O. Recall # Z-0923-05 REASON A defect in the software allows incorrect measurement results to be entered into the system’s built-in report. CODE Serial numbers(domestic) 20505841, 20505867, 20505884, 20505885, 20505886, 20505890, 20505898, 20505907, 20505908, 20505913,...Read More

Company: Philips Medical Systems North America CoDate of Enforcement Report: 7/6/05 Class: II PRODUCT View Forum 2003 software, SW 3.4L1, Recall # Z-0896-05 REASON Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10. CODE The firm utilizes site numbers: 534544,...Read More

Company: Misys Healthcare Systems,Date of Enforcement Report: 7/6/05 Class: II PRODUCT Misys Laboratory with Lab Access Results application for versions 5.3 and later. Recall # Z-0938-05 REASON Software anomaly may rarely allow modification of previously reported specimen results. CODE Versions 5.3 and later RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on May 13,...Read More