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External biphasic defibrillators, monitor/defibrillators and automated external defibrillators (AEDs) used to provide cardioversion therapy to patients are being investigated by the Food and Drug Administration following reports that the devices designed to deliver 200 J (joules) were ineffective during use.
A brand of external defibrillators designed for use during sudden cardiac arrest is being recalled by the manufacturer because the devices may fail, rendering them inoperable and preventing them from delivering therapy when needed, according to the Food and Drug Administration (FDA) MedWatch reporting system.
The Food and Drug Administration (FDA) and medical diagnostic equipment manufacturer Welch Allyn have issued a notice to health care professionals and consumers of a voluntary worldwide Class 1 Recall on more than 14,000 of its AED 10 Automatic External Defibrillator (AED) and the MRL JumpStart AED.
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