GE Healthcare Finland Oy - Class 1 Recall
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms) (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 8, 2023 Category: Medical Devices Source Type: alerts
Remote Diagnostic Technologies Ltd. - Tempus Pro - Class 2 Recall
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 2, 2021 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Azure - Class 2 Recall
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan. 2. Astra family: Astra XT DR MRI SureScan, Astra XT SR MRI SureScan. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2021 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Carelink - Class 2 Recall
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2021 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Carelink - Class 2 Recall
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2021 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Precepta - Class 2 Recall
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2021 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Percepta, Serena, and Solara CRTP MRI - Class 2 Recall
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT) (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2021 Category: Medical Devices Source Type: alerts
BIOTRONIK Inc - BIOTRONIK ILESTO 7 VRT - Class 2 Recall
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - 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 ILESTO 7 VRT - Class 2 Recall
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - 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 ITREVIA - Class 2 Recall
BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - 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 ILESTO 7 DRT - Class 2 Recall
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - 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 ILIVIA - Class 2 Recall
BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - 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 INTICA - Class 2 Recall
BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - 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 INTICA - Class 2 Recall
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - 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 ILIVIA - Class 2 Recall
BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - 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
