BIOTRONIK Inc - BIOTRONIK ILIVIA - Class 2 Recall
BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - 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-1, REF383562, UDI: 04035479125189 - 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 INVENTRA - Class 2 Recall
BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - 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 DX DF-1, REF 393037, UDI: 04035479129521 - 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 - BIOTRNIK IPERIA - Class 2 Recall
BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - 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 Iforia - Class 2 Recall
BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - 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 INVENTRA - Class 2 Recall
BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - 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 - 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 ILIVIA - Class 2 Recall
BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - 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 NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - 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
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Evera and Visia - Class 1 Recall
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2021 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Viva, Claria, Amplia, Compia, and Brava - Class 1 Recall
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachyca...
Source: Medical Device Recalls - March 28, 2021 Category: Medical Devices Source Type: alerts
Philips North America, LLC - Philips HeartStart MRx Monitor/Defibrillators - Class 2 Recall
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
ZOLL Medical Corporation - AED PRO - Class 2 Recall
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated ...
Source: Medical Device Recalls - July 4, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Implantable Cardioverter Defibrillator (NonCRT) - Class 2 Recall
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2018 Category: Medical Devices Source Type: alerts
