Company: Merge Healthcare, Inc. Date of Enforcement Report 11/6/2014 Class lI: PRODUCT Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data...Read More

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP). Date of Enforcement Report 11/6/2014 Class I: PRODUCT Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations. Recall Number Z-0112-2015 REASON A software issue may lead...Read More