The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MA
FDA device recall Z-2148-2015 · posted 2015-07-20 · Terminated
Recall details
- Recalling firm
- EKOS Corporation
- Reason for recall
- The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
- Action taken
- Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer. The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment. Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter. Customers with questions can contact EKOS Customer Service at 1-888-400-3567.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 46 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-06-24
- Date posted
- 2015-07-20
- Date terminated
- 2015-08-25
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT (K140151) | Btg International, Inc. | 2014-05-21 |
| EKOSONIC ENDOVASCULAR SYSTEM (K111705) | Ekos Corporation | 2011-08-03 |
| EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION (K081467) | Ekos Corp. | 2008-06-26 |