Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

ADULT Radiotransparent Electrode Recalled by Heart Sync, Inc. Due to Heart Sync Multi-function defibrillation electrodes will not connect...

Date: November 11, 2014
Company: Heart Sync, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Heart Sync, Inc. directly.

Affected Products

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.

Quantity: sold in boxes of ten electrodes: 4663.8 boxes; 46638 units total

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Heart Sync, Inc.

Heart Sync, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report