Device 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.
Z-0149-2023
Product summary
- Event
- Event 90984
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 consoles
- Official record key
device-enforcement:Z-0149-2023
Official wording
Reason: Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Code information: Serial numbers CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804, CU4.0-01835, CU4.0-01840, CU4.0-01843, CU4.0-01897, CU4.0-01980, CU4.0-02022, CU4.0-02146, and CU4.0-02026, UPN 600-40500, GTIN 00858593006462.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.