Lysus Infusion System - PT-3 Control . The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 wat
FDA device recall Z-0175-06 · posted 2005-11-23 · Terminated
Recall details
- Recalling firm
- Ekos Corp
- Reason for recall
- Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.
- Action taken
- On 1/19/05 the firm began visiting consignees and upgrading software.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 7
- Distribution
- The device was distributed to 6 hospitals/medical centers; 1 each located in AZ, OH, WA, FL, IL, and. CA. One consignee is located Germany.
- Date initiated
- 2005-01-18
- Date posted
- 2005-11-23
- Date terminated
- 2005-11-29
- 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 |
|---|---|---|
| Lysus Infusion System (K042456) | Ekos Corp. | 2004-09-23 |