Baxter Healthcare Corporation - Class 2 Recall
Baxter Electrocardiograph, ELI 380 -DCS21 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 25, 2023 Category: Medical Devices Source Type: alerts
Welch Allyn Inc Mortara - ELI, Burdick and McKesson brand 280 Resting Electrocardiographs - Class 2 Recall
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LD...
Source: Medical Device Recalls - October 3, 2021 Category: Medical Devices Source Type: alerts
Abbott Laboratories Inc. (St Jude Medical) - WorkMate Claris System Display, Model H700124 - Class 2 Recall
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2021 Category: Medical Devices Source Type: alerts
Abbott Laboratories Inc. (St Jude Medical) - WorkMate Claris System, Model H700123 - Class 2 Recall
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2021 Category: Medical Devices Source Type: alerts
Welch Allyn Inc Mortara - ELI 380 - Class 2 Recall
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2021 Category: Medical Devices Source Type: alerts
Welch Allyn Inc Mortara - ELI 280 - Class 2 Recall
ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2021 Category: Medical Devices Source Type: alerts
WELCH ALLYN, INC/MORTARA - ELI 380 Electrocardiograph - Class 2 Recall
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 10, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - MAC VU360, Electrocardiograph - Class 2 Recall
MAC VU360, Electrocardiograph (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 8, 2020 Category: Medical Devices Source Type: alerts
WELCH ALLYN, INC/MORTARA - ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, - Class 2 Recall
Lead diagnostic electrocardiograph capable of acquiring, viewing, transmitting, printing, and storing ECG data. ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio - Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2020 Category: Medical Devices Source Type: alerts
WELCH ALLYN, INC/MORTARA - X12 - Class 2 Recall
X12+. The X12+ represents state-of-the-art wireless electrocardiographic technology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2020 Category: Medical Devices Source Type: alerts
WELCH ALLYN, INC/MORTARA - T12 - Class 2 Recall
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2020 Category: Medical Devices Source Type: alerts
WELCH ALLYN, INC/MORTARA - Class 2 Recall
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2020 Category: Medical Devices Source Type: alerts
Physio-Control, Inc. - LifePak 500 Automatic external Defibrillator - Class 2 Recall
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 2, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - MAC VU360 - Class 2 Recall
MAC VU360, Model Number 2030360-001, Electrocardiograph (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 24, 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
