FDA recall Z-0149-2023

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.

Reason for recall

Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

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.

Key facts

Status

Ongoing

Initiation date

2022-10-13

Report date

2022-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0149-2023