Heart Sync, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0584-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: November 11, 2014

Date Posted: December 31, 2014

Recall Number: Z-0584-2015

Event ID: 69875

Reason for Recall:

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

Status: Terminated

Product Quantity: sold in boxes of ten electrodes: 116 boxes; 1160 units total

Code Information:

All Lots. Catalog / Part Number C100AC-PHILIPS

Distribution Pattern:

Worldwide Distribution - USA (Nationwide) in the states of NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, MA, and PR; and countries of: Thailand and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated