Recall Z-0175-06 ยท KRA Catheter, Continuous Flush
Ekos Corp
Lysus Infusion System - PT-3 Control . The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus Infusion System consists of three m
| Date | Nov 23, 2005 (initiated Jan 18, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On 1/19/05 the firm began visiting consignees and upgrading software. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042456 | Lysus Infusion System Ekos Corp., Sep 23, 2004 |