The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer)
FDA device recall Z-0133-2014 · posted 2013-11-01 · Terminated
Recall details
- Recalling firm
- EKOS Corporation
- Reason for recall
- The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
- Action taken
- EKOS notified their customer by email on October 2, 2013, about the recall. EKOS has requested the customer to return of EkoSonic Control Unit PT3B-783, so that it can be replaced. CORRECTIVE ACTION: This single affected unit will be reworked with the correct power entry module and released into finished goods as a refurbished control unit. EKOS did not distributed any affected devices in the US. For any questions, please call EKOS Corporation at 425-415-3100.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- one unit
- Distribution
- Worldwide Distribution in Germany only.
- Date initiated
- 2013-10-02
- Date posted
- 2013-11-01
- Date terminated
- 2013-11-22
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EKOSONIC ENDOVASCULAR SYSTEM (K111705) | Ekos Corporation | 2011-08-03 |
| EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION (K081467) | Ekos Corp. | 2008-06-26 |