Company:Philips Healthcare Inc. Date of Enforcement Report 8/22/12 Class ll: PRODUCT Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use. Z-2208-2012 REASON Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting...Read More

Company:AGFA Corp. . Date of Enforcement Report 8/22/12 Class ll: PRODUCT IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) All software versions. Recall Number Z-2184-2012 REASON Content entered into the “Conclusions” free text box on the Report Writer screen was not represented...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 8/22/12 Class ll: PRODUCT GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced...Read More