GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE LOGIQ E9 ultrasound system - Class 2 Recall
GE LOGIQ E9 ultrasound system Product Usage: 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; Transesophageal and Intraoperative (abdominal, thoracic and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE LOGIQ 9 ultrasound system - Class 2 Recall
GE LOGIQ 9 ultrasound system Product Usage: 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; Transesophageal and Intraoperative (abdominal, thoracic and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E90 ultrasound system - Class 2 Recall
GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoraci...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid 7 ultrasound system - Class 2 Recall
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic,...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E7 ultrasound system - Class 2 Recall
GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - RAPIDLab 1245 System - Class 2 Recall
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - RAPIDPoint 405 System - Class 2 Recall
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - RAPIDPoint 500 System - Class 2 Recall
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - RAPIDLab 1265 System - Class 2 Recall
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Philips SureSigns VSV (Vital Signs Viewer) - Class 2 Recall
Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2018 Category: Medical Devices Source Type: alerts
Datex-Ohmeda, Inc. - Neonatal Flow Sensor Cable - Class 2 Recall
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 9, 2018 Category: Medical Devices Source Type: alerts
Vyaire Medical - AirLife Resuscitation Device - Class 1 Recall
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own...
Source: Medical Device Recalls - August 9, 2018 Category: Medical Devices Source Type: alerts
NEONATAL VITAMIN Tablet [NEOMED PHARMACEUTICAL]
Updated Date: Aug 3, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 3, 2018 Category: Drugs & Pharmacology Source Type: alerts
NEONATAL PLUS VITAMIN Tablet [NEOMED PHARMACEUTICAL]
Updated Date: Aug 3, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 3, 2018 Category: Drugs & Pharmacology Source Type: alerts
Smiths Medical ASD Inc. - BCI Advisor Vital Signs Monitor, Model 9200 - Class 2 Recall
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead/5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 ...
Source: Medical Device Recalls - July 7, 2018 Category: Medical Devices Source Type: alerts
