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 main components, a single use Lysus Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus Infusion Catheter System.
FDA Recall Z-0175-06 · Posted 2005-11-23
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Recalling FirmEkos Corp
Recall StatusTerminated
Product CodeKRA
Date Initiated2005-01-18
Date Terminated2005-11-29
Product Quantity7
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.
Firm Action
On 1/19/05 the firm began visiting consignees and upgrading software.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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