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U.S. Department of Health and Human Services

Class 2 Device Recall EKOS Lysus Infusion System

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  Class 2 Device Recall EKOS Lysus Infusion System see related information
Date Initiated by Firm January 18, 2005
Date Posted November 23, 2005
Recall Status1 Terminated 3 on November 29, 2005
Recall Number Z-0175-06
Recall Event ID 33408
510(K)Number K042456  
Product Classification Catheter, Continuous Flush - Product Code KRA
Product 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.
Code Information Serial numbers PT3-002, PT3-006, PT3-007, PT3-009, PT3-012, PT3-013, PT3-014
Recalling Firm/
Manufacturer
Ekos Corp
22030 - 20th Ave SE, Ste 101
Bothell WA 98021
For Additional Information Contact Jocelyn Kersten
425-482-1108 Ext. 287
Manufacturer 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.
FDA Determined
Cause 2
Other
Action On 1/19/05 the firm began visiting consignees and upgrading software.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = EKOS CORP.
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