GE Healthcare - Dfend and Dfend water trap - Class 2 Recall
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patient s respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilatio...
Source: Medical Device Recalls - May 29, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - DatexOhmeda S/5MT Compact Airway Module - Class 2 Recall
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. Product Usage: The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patient s respiration (CO2, 02, N20, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption V02, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N20+02 mixtures. The device is indicated for use by qualified me...
Source: Medical Device Recalls - June 18, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. - Class 2 Recall
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive bloo...
Source: Medical Device Recalls - March 12, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - CARESCAPE Monitor B850 - Class 2 Recall
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (F...
Source: Medical Device Recalls - February 5, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. - Class 2 Recall
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, car...
Source: Medical Device Recalls - January 29, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - CARESCAPE Monitor B850 - Class 2 Recall
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Tra...
Source: Medical Device Recalls - June 22, 2013 Category: Medical Equipment Source Type: alerts
