BIOTRONIK Inc - BIOTRNIK INVENTRA - Class 2 Recall
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 22, 2021 Category: Medical Devices Source Type: alerts
BIOTRONIK Inc - BIOTRONIK IPERIA - Class 2 Recall
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 22, 2021 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - DYNAGEN EL ICD DR - Class 2 Recall
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2020 Category: Medical Devices Source Type: alerts
St Jude Medical, Cardiac Rhythm Management Division - Confirm Rx - Class 2 Recall
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk ...
Source: Medical Device Recalls - January 14, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - ApexPro Telemetry System - Class 2 Recall
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems ...
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts
Cardiocommand Inc. - Transesophageal Cardiac Pacing and Recording System - Class 3 Recall
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial...
Source: Medical Device Recalls - June 13, 2019 Category: Medical Devices Source Type: alerts
St Jude Medical Inc. - St. Jude Medical Confirm Rx Insertable Cardiac Monitor - Class 2 Recall
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are suscepti...
Source: Medical Device Recalls - April 26, 2019 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - Delta, Delta XL, Kappa - Class 2 Recall
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2019 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
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
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - EnTrust Single Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies - Class 2 Recall
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies an - Class 2 Recall
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Medtronic EnTrust Escudo D144VRC - Class 2 Recall
Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - EnTrust Single Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies - Class 2 Recall
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
