Class 1 Recall: CONMED Corporation, PadPro and R2 Multi-Function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs

Recall Class: Class I

Date Recall Initiated: November 6, 2014

Devices:

All lot codes of the following AED electrodes distributed between March 1, 2012 – October 29, 2014.

• Adult Radiotransparent Electrode
  • Catalog Number: 2001H, 2001H-C, 2001H-PC, 2516H, 2516H-PC
• Pediatric Radiotranslucent Electrode
  • Catalog Number: 2603H
• Mini Pediatric Radiotranslucent Electrode
  • Catalog Number: 2602H
• Pediatric R2 Multifunction Electrode
  • Catalog Number: 3115-1750
• R2 Multifunction Electrode
  • Catalog Number: 3115-1751

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 
CONMED Corporation
525 French Road
Utica, NY 13502-5994

Reason for Recall: 
Philips made changes to the connector design of their FR3 and FRx AEDs. Because of these changes, the CONMED electrodes will no longer work with these AEDs.

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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