Heart Sync, Inc.: Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the

Agency Publication Date: December 24, 2014

Affected Products

Product: ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

All Lots. Catalog / Part Number C100-PHILIPS

Product: ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

All Lots. Catalog / Part Number C100AC-PHILIPS

Product: ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

All Lots. Catalog / Part Number T100LO-PHILIPS

Product: ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

All Lots. Catalog / Part Number T100-PHILIPS

Product: ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

All Lots. Catalog / Part Number T100AC-PHILIPS

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69875

Status: Resolved

Manufacturer: Heart Sync, Inc.

Manufactured In: United States

Units Affected: 5 products (sold in boxes of ten electrodes: 4663.8 boxes; 46638 units total; sold in boxes of ten electrodes: 116 boxes; 1160 units total; sold in boxes of ten electrodes: 1791.3 boxes; 17913 units total; sold in boxes of ten electrodes: 4692.9 boxes; 46929 units total; sold in boxes of ten electrodes: 209 boxes: 2090 units total)

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Sources: FDA iRES · Raw API Response

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