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Boston Scientific Corporation recalls EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use
Recalled December 23, 2020 · FDA recall Z-0637-2021 · Boston Scientific
Hazard
This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles. · FDA Class II
Units
90 (OUS)
Sold at
No US distribution. Foreign distribution to Latin America and EU.
Description
This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.
Product
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →