Maquet Cardiovascular Us Sales, Llc - Quadroxi Neonatal Oxygenator - Class 1 Recall
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2018 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - QUADROXi Neonatal oxygenator - Class 1 Recall
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Incubator, Neonatal - Class 2 Recall
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 20, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Incubator, Neonatal - Class 2 Recall
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 20, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Aisys Anesthesia System - Class 2 Recall
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended...
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Aisys Anesthesia System - Class 2 Recall
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI envi...
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts
Fresenius Vial Sa - Volumat MC Agilia - Class 2 Recall
Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV...
Source: Medical Device Recalls - November 2, 2018 Category: Medical Devices Source Type: alerts
PerkinElmer Life and Analytical Sciences, Wallac, OY - AutoDELFIA Neonatal IRT kit - Class 3 Recall
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 12, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare Finland Oy - GE Healthcare CARESCAPE Monitor B850 - Class 2 Recall
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. 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 is indicated for monitoring of: -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 - October 11, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare Finland Oy - GE Healthcare CARESCAPE Monitor B450 - Class 2 Recall
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse ox...
Source: Medical Device Recalls - October 11, 2018 Category: Medical Devices Source Type: alerts
Neomed Inc - Enteral Feeding Tubes - Class 2 Recall
NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use. Product Usage: Intended for use in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement and is not intended for use beyond 30 days. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 11, 2018 Category: Medical Devices Source Type: alerts
Agfa Healthcare NV - Agfa DXD 600 system - Class 2 Recall
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL - GE Vivid E95 ultrasound system - Class 2 Recall
GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; 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 Intraoperative (abdominal, thoracic, & 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 E9 ultrasound system - Class 2 Recall
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; 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 Intraoperative (abdominal, Thoracic, & 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 E80 ultrasound system - Class 2 Recall
GE Vivid E80 ultrasound system 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, thoracic, & va...
Source: Medical Device Recalls - September 7, 2018 Category: Medical Devices Source Type: alerts
