EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Reported: November 9, 2022 Initiated: October 13, 2022 #Z-0149-2023
Product Description
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 for Recall
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 16 consoles
- Distribution
- Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.. Recalled by Boston Scientific Corporation. Units affected: 16 consoles.
Why was this product recalled? ▼
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 9, 2022. Severity: Moderate. Recall number: Z-0149-2023.
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