Device recall
Z-0353-2018: LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The…
FDA device recall · Class II · Zoll Manufacturing Corp.
Key facts
| Recall number (Z-number) | Z-0353-2018 |
|---|---|
| Recall event | 78926 |
| Product | 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. |
| Product code | MVK |
| Recalling firm | Zoll Manufacturing Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2021 |
| PMA numbers | P010030 |
| FEI number | 3008642652 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database