Reported Nov 9, 2022 · Ongoing
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
- Lot codes and dates
Serial numbers CU4.0-01438CU4.0-01524CU4.0-01545CU4.0-01560CU4.0-01598CU4.0-01610CU4.0-01676CU4.0-01804CU4.0-01835CU4.0-01840CU4.0-01843CU4.0-01897CU4.0-01980CU4.0-02022CU4.0-02146and CU4.0-02026UPN 600-40500GTIN 00858593006462
- Amount recalled
- 16 consoles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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