EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovasc

FDA device recall Z-0149-2023 · posted 2022-10-28 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

The recalling firm issued customer letters dated 10/13/2022 via FedEx overnight delivery on 10/13/2022 informing the customer certain serial numbers of the control units were shipped without an instruction for use (IFU) or contained an incorrect IFU. The customer was requested to complete and return the acknowledgment form to indicate receipt of the letter and the EKOS Control Unit 4.0 Instructions for Use (IFU). If the customer is a distributor, they are to follow the attached instructions (complete and return the acknowledgment form and place the provided IFU with their EKOS Control Unit 4.0 Console) and forward the notification to their customers. If the customer is a facility that has sent products to another hospital within their network, they are to follow the same attached instructions and ensure the notification is forwarded to the other hospitals if necessary.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QEY

Quantity affected

16 consoles

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.

Date initiated

2022-10-13

Date posted

2022-10-28

Location

Maple Grove, MN

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