Reported Jan 24, 2018 · Terminated
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients…
Zoll Manufacturing Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zoll Manufacturing Corp. · 121 Gamma Dr · Pittsburgh, PA · 15238-2919
Is this the product you have?
- LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
- Lot codes and dates
- All Serial Numbers
- Amount recalled
- 33,670 units
Where it was sold
- Nationwide
Why it was recalled
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Zoll Manufacturing Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.