Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 9/16/2015 Class lI: PRODUCT Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate....Read More

Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report 9/16/2015 Class lI: PRODUCT CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. Recall Number Z-2742-2015 REASON Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and...Read More