FDA Device recall Z-0149-2023
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System
- FDA Device
- Class II
- ongoing
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System by Boston Scientific, citing consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0149-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-13 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | CA, IL, KY, OH, OK, RI, TX |
Product
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Reason
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Identifiers
| code_info | Serial numbers CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804,…Serial numbers CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804, CU4.0-01835, CU4.0-01840, CU4.0-01843, CU4.0-01897, CU4.0-01980, CU4.0-02022, CU4.0-02146, and CU4.0-02026, UPN 600-40500, GTIN 00858593006462. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0149-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.