Company: Philips Electronics North America Corporation Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. Recall Number Z-1246-2017 REASON Eye Station images were not importing properly and were imported under...Read More

Company: Tosoh Smd Inc Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. Recall Number Z-1245-2017...Read More