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FDA Issues Class 1 Recall for ConMed Defibrillator Electrodes

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Demetria Ratchford3 years ago

Multiple ConMed defibrillator electrodes have been recalled due to concerns that the devices may malfunction when used with updated defibrillators.

About the Electrode Recall

The U.S. Food and Drug Administration (FDA) has recently assigned a Class I recall status to several lines of ConMed defibrillator electrodes due to malfunctions with a number of updated devices made by Royal Phillips defibrillators.

The changes made by Philips to the connector design of the FR3 and FRx automatic external defibrillators were unable to work with some models of ConMed’s electrodes. The FDA warns that the FR3 device does not require pre-connected electrode pads, so users will not know if the pads will work until they try to use the defibrillator.

According to the federal watchdog agency, this poses a risk because treatment delays in serious situations could seriously injure or kill the affected patients.

Description of Electrode Recall

  • ConMed has decided to recall the following products:
    • Adult radio transparent electrode
    • Pediatric radiotranslucent electrode
    • Mini pediatric radiotanslucent electrode
    • R2 multifunction electrode
    • Pediatric R2 multifunction electrode
  • The ConMed electrodes still work with Philips AEDs that accept plug style connectors.
  • The affected products were distributed between March 1st, 2012 and October 29th, 2014.
  • The recall began on November 6th with an “Urgent Device Correction” letter alerting customers to the problem and informing them of company revised labeling for the electrodes.

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