Drug recall
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
FDA recall event 84170 · Class II · LivaNova USA Inc
Key facts
| Event ID | 84170 |
|---|---|
| Recall numbers | Z-0663-2020 |
| Recalling firm | LivaNova USA Inc |
| Product type | Devices |
| Products | VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system… |
| Initiation date | Nov 16, 2018 |
| Report date | Dec 18, 2019 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 1000117004 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: