Heart Sync Recalling Electrodes Used with Philips Defibrillators
Ann Arbor, Mich.-based Heart Sync is recalling its Adult Radiotransparent, Adult/Child Radiotransparent, Radiotranslucent and Adult/Child Radiotranslucent Electrodes due to design changes Philips made to its FR3 and FRx automatic external defibrillators, which render the electrodes useless.
This is the second time in a month that a manufacturer has been forced to recall electrodes due to Philips design changes. CONMED issued a similar Class I recall on Dec. 5.
According to Heart Sync’s Class I recall notice, first responders and healthcare providers won’t know the electrode pads don’t work until they attempt to use the defibrillator. This may delay the delivery of electrical therapy to revive a patient, potentially causing serious injury or death, the notice says.
The company sent a voluntary field safety alert to customers on Nov. 11, asking them to stop using its electrodes with the FR3 and FRx defibrillator and only use Philips brand electrodes listed in the device manual. The recall notice was posted recently to the FDA’s website.
The recall includes all units distributed between Oct. 26, 2011, and Nov. 26, 2014. Heart Sync stresses that its electrodes will still work with other Philips AEDs that accept plug style connectors.
View the recall notice at www.fdanews.com/01-05-15-HeartSyncRecall.pdf. — Kellen Owings