Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report:11/14/2007 Class:ll PRODUCT The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application. All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is...Read More

Company: Medtronic Inc. Cardiac Rhythm Management Date of Enforcement Report:11/14/2007 Class:lll PRODUCT Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall...Read More

Company:GE Healthcare Date of Enforcement Report:11/14/2007 Class:ll PRODUCT GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; Recall # Z-0113-2008 REASON When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is...Read More