Royal Philips Electronics N.V. Defibrillator Updates Spur ConMed Corporation Electrode Recall
A ConMed (NSDQ:CNMD) recall of several lines of electrodes because they won't work properly with some Royal Philips (NYSE:PHG) defibrillators was given the most-serious Class I designation by the FDA.
The FDA said changes made by Philips to the connector design of its FR3 and FRx automatic external defibrillators rendered some models of ConMed's electrodes unable to work with those devices.
Although the FRx defibrillator is designed to sound a continuous alarm if the pads are not connected, the FDA warned that the FR3 device does not require pre-connected electrode pads, so users will not know if the pads won't work until they try to use the defibrillator.
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The FDA said changes made by Philips to the connector design of its FR3 and FRx automatic external defibrillators rendered some models of ConMed's electrodes unable to work with those devices.
Although the FRx defibrillator is designed to sound a continuous alarm if the pads are not connected, the FDA warned that the FR3 device does not require pre-connected electrode pads, so users will not know if the pads won't work until they try to use the defibrillator.
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