EKOS Control Unit 4.0 console recall
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Why was EKOS Control Unit 4.0 console recalled?
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 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.
- Recall date
- November 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)