FDA Device

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 Ca

Hazard

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.

What You Should Do

Remedy

On 1/19/05 the firm began visiting consignees and upgrading software.

Products

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 physic
Brand
Ekos Corp
UPC
Serial numbers PT3-002, PT3-006, PT3-007, PT3-009, PT3-012, PT3-013, PT3-014

Units Affected

7