FDA issues Safety Alert for Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
Editor's Note
The Food & Drug Administration (FDA) on January 17 issued a Safety Alert for the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator because of concerns that the device may fail to deliver treatment to patients if the device is not replaced soon after displaying “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102.”
Failure to contact Zoll and immediately replace the device after Message Code 102 appears may result in serious patient harm or death because the device may fail to deliver a “treatment shock” when needed.
The FDA is aware of one patient death resulting from the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed. Zoll Medical (Chelmsford, Massachusetts) issued a voluntary recall of the LifeVest 4000 on January 14.
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