GE Healthcare, LLC - GE Healthcare, LOGIQ e Ultrasound System. - Class 2 Recall
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for mo...
Source: Medical Device Recalls - August 2, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM - Class 2 Recall
GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 1, 2013 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
Embla System Llc - Embletta Gold - Class 2 Recall
embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient. Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328...
Source: Medical Device Recalls - June 12, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare, CARESCAPE Monitor B650 - 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcarr Dash Port 2 Docking Station - Class 2 Recall
GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. - Class 2 Recall
Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. 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 - February 14, 2013 Category: Medical Equipment Source Type: alerts
Mindray DS USA, Inc. d.b.a. Mindray North America - Mindray DS USA Inc. - Class 2 Recall
DPM5 Monitor Product Usage: A vital signs monitor used on human patients. The target populations are adult, pediatric, and neonatal patients. The DPM5 Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and intuitive menu system. The patient parameters that can be monitored by DPM5 monitors are ECG (3- lead or 5-lead selectable), Heart Rate (HR), Pulse Rate(PR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP) , Saturation of Pulse Oxygen (SpO2), Temperature (TEMP), Invasive Blood Pressure (IBP), Carbon Dioxide (CO), Anesthetic Gases (AG) . Its design allows the...
Source: Medical Device Recalls - January 28, 2013 Category: Medical Equipment Source Type: alerts
Perkinelmer - Perkin Elmer NEONATAL TOTAL GALACTOSE KIT - Class 2 Recall
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts
