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Boston Scientific Corporation recalls EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovasc
Recalled November 9, 2022 · FDA recall Z-0149-2023 · Boston Scientific
Hazard
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. · FDA Class II
Units
16 consoles
Sold at
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.
Description
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
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.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →