The Lysus Infusion System - Catheter Interface Cable. The Lysus Infusion System employs high frequency (2-2.5 MHz), low
FDA device recall Z-0110-06 · posted 2005-11-01 · Terminated
Recall details
- Recalling firm
- Ekos Corp
- Reason for recall
- The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable.
- Action taken
- On 9/21/04 the firm began visiting customers and replacing the catheter interface cables.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 3
- Distribution
- Units were shipped to hospitals, one each in WA, AZ, and OH.
- Date initiated
- 2004-09-21
- Date posted
- 2005-11-01
- Date terminated
- 2005-11-08
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Lysus Infusion System (K042456) | Ekos Corp. | 2004-09-23 |