Drug recall
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the…
FDA recall event 90984 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 90984 |
|---|---|
| Recall numbers | Z-0149-2023 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. |
| Initiation date | Oct 13, 2022 |
| Report date | Nov 9, 2022 |
| City | Maple Grove |
| State | MN |
| Country | United States |
| FEI number | 3002095335 |
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: