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
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
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
St Jude Medical Inc. - Merlin PCS Programmer Software - Class 2 Recall
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2018 Category: Medical Devices Source Type: alerts
Spacelabs Healthcare Inc - Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1 - Class 2 Recall
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 26, 2018 Category: Medical Devices Source Type: alerts
Scottcare Corporation - TeleSentry - Class 2 Recall
TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2016 Category: Medical Equipment Source Type: alerts
St Jude Medical - TactiSys Quartz Pack, PN004 400 - Class 2 Recall
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2015 Category: Medical Equipment Source Type: alerts
Atricure Inc - cryoICE cryoablation probe (CRYO2) - Class 2 Recall
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 31, 2014 Category: Medical Equipment Source Type: alerts
Covidien LLC - Kendall - Class 1 Recall
MediChoice¿ Multifunction Electrode; Part Number: MC171 OH. Adult/Child Radiotransparent Multifunction Defibrillation Electrode pads used for defibrillation, pacing, monitoring and cardioversion. The Medi-Trace Cadance Defibrillation Electrodes are used in combination with a defibrillator to deliver a therapeutic dose of electrical current to the patient's heart for the purpose of treating life threatening cardiac arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2014 Category: Medical Equipment Source Type: alerts
Covidien LLC - Kendall - Class 1 Recall
Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660. The Medi-Trace" Cadence QC RTS Electrode is intended for K012218 use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. The product is used in connection with a defibrillator to deliver a therapeutic dose of electrical current to the patients heart for the purpose of treating life-threatening cardiac arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2014 Category: Medical Equipment Source Type: alerts
Covidien LLC - Class 1 Recall
Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected; Part Number: 22660PC The Medi-Trace" Cadence QC RTS Electrode is intended for K012218 use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. The product is used in connection with a defibrillator to deliver a therapeutic dose of electrical current to the patients heart for the purpose of treating life-threatening cardiac arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2014 Category: Medical Equipment Source Type: alerts
Covidien LLC - Class 1 Recall
Covidien Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Radiotransparent; Part Number: 22660R The Medi-Trace" Cadence QC RTS Electrode is intended for K012218 use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. The product is used in connection with a defibrillator to deliver a therapeutic dose of electrical current to the patients heart for the purpose of treating life-threatening cardiac arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2014 Category: Medical Equipment Source Type: alerts
