A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall – Defective Component. According to the Food & Drug Administration FDA’s MedWatch:
Unexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall – Defective Component.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
If you have thoughts on the drug or medical device recall or safety alert, share your drug or medical device recall or safety alert comments below.