Electrode, Electrocardiograph

ECG Electrodes:

There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.

Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547.

The electrodes may fail to transmit signals.

Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003

Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.

3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.

The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response.

The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.

Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.

Unilect ECG Electrodes

In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.

1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packa

Separation of the sensing element from the body of the electrode.

1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Ca

Separation of the sensing element from the body of the electrode.

3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electro

Potential for breakage of the ECG electrode carbon stud from the eyelet.

Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel

Corrosion could cause performance failures in the product.