Class 1 Recall: Heart Sync, Multi-function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs

This recall was updated on January 8, 2015.

Recall Class: Class I

Date Recall Initiated: November 11, 2014

Devices:

All lot codes of the following AED electrodes distributed between October 26, 2011 and November 26, 2014

• Adult Radiotransparent Electrode
  • Catalog Number C100-PHILIPS
• Adult/Child Radiotransparent Electrode
  • Catalog Number C100AC-PHILIPS
• Adult Radiotransparent Electrode
  • Catalog Number T100LO-PHILIPS
• Radiotranslucent Electrode
  • Catalog Number T100-PHILIPS
• Adult/Child Radiotranslucent Electrode
  • Catalog Number T100AC-PHILIPS

NOTE: These electrodes will work with other Philips AEDs that accept plug style connectors.

Use: Electrodes are connected to an automatic external defibrillator (AED), which analyzes the heart rhythm in cardiac arrest patients and delivers an electrical shock to restore normal heart rhythm. The primary users of AEDs are first responders and hospital health care providers.

Recalling Firm 
Heart Sync, Inc.
5643 Plymouth Road
Ann Arbor, Michigan 48105-9586

Reason for Recall:

These defibrillation electrodes have been recalled due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.

The FRx AED requires electrode pads be connected to the device before it is used. The AED will make a continuous alarm chirp to alert the user that the correct pads are not connected.

The FR3 does not require electrode pads to be pre-connected. Users will not know that the pads do not work until they try to use the AED. This may result in a delay in delivering the electrical therapy needed to revive a patient.

Delay in therapy could result in serious injury or death.

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