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 Endovascular System.
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Read the official notice →- Date
- 2022-11-09
- Country
- United States
- Brand
- Boston Scientific
- 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.
- Classification
- Class II
- Units
- Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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