Philips North America, LLC - PageWriter TC30 w/ trolley Government Bundle - Class 2 Recall
PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - PageWriter - Class 2 Recall
PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - PageWriter TC30 with out trolley Government Bundle - Class 2 Recall
PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - PageWriter TC70 - Class 2 Recall
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - PageWriter TC30 - Class 2 Recall
PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - PageWriter TC50 Government Bundle - Class 2 Recall
PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - PageWriter TC70 w/o trolley Government Bundle - Class 2 Recall
PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - PageWriter TC20 - Class 2 Recall
PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - PageWriter TC50 - Class 2 Recall
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2019 Category: Medical Devices Source Type: alerts
Invivo Corporation - Xper Flex Cardio - Class 2 Recall
Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts
Invivo Corporation - Flex Cardio Patient Monitoring System - Class 2 Recall
Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbo...
Source: Medical Device Recalls - November 10, 2017 Category: Medical Devices Source Type: alerts
Blackrock Microsystems, LLC - Blackrock NeuroPort Biopotential Signal Processing System - Class 2 Recall
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts
Blackrock Microsystems, LLC - Blackrock NeuroPort Biopotential Signal Processing System - Class 2 Recall
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts
Partners In Medicine Llc - Task Force Monitor 3040 - Class 2 Recall
CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be ...
Source: Medical Device Recalls - January 5, 2016 Category: Medical Equipment Source Type: alerts
Spacelabs Healthcare Inc - Spacelabs Healthcare CardioCall ECG Event Recorder - Class 2 Recall
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The event recorder, called the CardioCall, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the so-called Looping mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the Post-Activation mode, in which the device ...
Source: Medical Device Recalls - October 30, 2015 Category: Medical Equipment Source Type: alerts
