Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/26/2015 Class lI: PRODUCT Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall Number Z-2404-2015 REASON in case a system error occurs and the system enters the “Bypass Fluoro”...Read More

Company: Covidien LP Date of Enforcement Report 8/262015 Class l: PRODUCT Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). Recall Number Z-2329-2015 REASON Reports...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 8/26/2015 Class l: PRODUCT Alaris Syringe Pump, Model No. 8110. Delivers fluids. Recall Number Z-2362-2015 REASON Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump...Read More