Spacelabs Healthcare, Llc - ARIATELE TELEMETRY TRANSMITTER, Model 96281 - Class 2 Recall
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 31, 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 - Solar 8000 and Transport Pro with Patient Data Module (Marketed as CARESCAPE Patient Data Module) - Class 2 Recall
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic,...
Source: Medical Device Recalls - January 23, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - TRAM module - Class 2 Recall
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one...
Source: Medical Device Recalls - January 23, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Dash 3000/4000/5000 Patient Monitor - Class 2 Recall
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited ...
Source: Medical Device Recalls - January 23, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare Carescape Patient Data Module - Class 2 Recall
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 - Class 2 Recall
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric n...
Source: Medical Device Recalls - December 13, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare It - Centricity Perinatal and Centricity Intensive Care - Class 2 Recall
Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to docu...
Source: Medical Device Recalls - November 19, 2013 Category: Medical Equipment Source Type: alerts
Carefusion 211 Inc dba Carefusion - AVEA Ventilator - Class 1 Recall
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 28, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - CARESCAPE Monitor 650 - Class 2 Recall
GE Healthcare, 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 EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature a...
Source: Medical Device Recalls - September 20, 2013 Category: Medical Equipment Source Type: alerts
HemoCue AB - HemoCue Glucose 201 Microcuvettes - Class 2 Recall
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Dash 3000/4000/5000 Patient Monitor - Class 2 Recall
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Solar 8000 and Transport Pro with Patient Data Module (Marketed as CARESCAPE Patient Data Module) - Class 2 Recall
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - TRAM module - Class 2 Recall
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - LOGIQ S8 Ultrasound System - Class 2 Recall
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 10, 2013 Category: Medical Equipment Source Type: alerts
