FDAClass IIJanuary 24, 2018

LifeVest Wearable Defibrillator recall

LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who…

Why was LifeVest Wearable Defibrillator recalled?

Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Serial Numbers

Product
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who…
Recalling firm
Zoll Manufacturing Corp.
Quantity
33,670 units
Distribution
US Nationwide
Recall date
January 24, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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