FDA-Device2022-11-09Class II
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Boston Scientific Corporation
Hazard
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Sold states
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.
Affected count
16 consoles
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0149-2023Don't want to check this manually?
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