60 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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IntelliVue X3 Patient Monitor.
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code MHX·November 17, 2017
Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014
SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4" display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4" display or 3/5 Lead ECG, NBP, Temp, optional SPo2 option IBP Bedside Patient Monitor with 8.4" display VM8 3/5 Lead ECG, NBP, Temp, IPB, ET CO2, SPo2 Bedside Patient Monitor with 10" display or 3/5 Lead ECG, NBP, Temp, IPB, SPo2 Bedside Patient Monitor with 10" display Part number: VM3: 863077,453564041661,453564050161, VM4: 863063,453564024371,453564021961, 453564024401,453564021971 VM6: 863064,863065,453564024421,453564022001, 453564024441 VM8: 453564022041,863066,863068,453564022081, 453564024461, 453564024481 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MHX·October 30, 2009
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Recall
Open, Classified
·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017
Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).
FDA Recall
Terminated
·Suntech Medical, Inc.·Product code DXN·December 11, 2019
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Recall
Open, Classified
·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017
SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Recall
Open, Classified
·Philips North America, LLC·Product code MHX·April 19, 2019
SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Recall
Open, Classified
·Philips North America, LLC·Product code MHX·April 19, 2019
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Recall
Open, Classified
·Philips North America, LLC·Product code MHX·April 19, 2019
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Recall
Open, Classified
·Philips North America, LLC·Product code MHX·April 19, 2019
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Recall
Open, Classified
·Philips North America, LLC·Product code MHX·April 19, 2019
SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Recall
Open, Classified
·Philips North America, LLC·Product code MHX·April 19, 2019
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Recall
Open, Classified
·Philips North America, LLC·Product code MHX·April 19, 2019
Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014
Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014
Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014
Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code LDY·September 17, 2014
GE Healthcare, Dash 3000/4000/5000. 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 to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes, but is not limited to: electrocardiogram, invasive blood pressure, noninvasive blood pressure (NBP), heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORKTM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MHX·June 26, 2012