BEUDAMED
    FDA Recall Terminated

    PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised of a Drug Delivery Catheter (CD) and removable Ultrasound Core (USC) and a reusable EKOS PT-3B Control System. Box is labeled EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core

    Recall: Z-1752-2008 · Initiated March 10, 2008

    Recall

    Recall Number
    Z-1752-2008
    Event Number
    47245
    Firm
    EKOS Corporation
    FEI Number
    3001627457
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 10, 2008
    Posted
    September 2, 2008
    Terminated
    May 13, 2011
    Address
    11911 N Creek Pkwy S, Bothell, WA, 98011-8809

    Description

    PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised of a Drug Delivery Catheter (CD) and removable Ultrasound Core (USC) and a reusable EKOS PT-3B Control System. Box is labeled EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core

    Reason

    Potential for unit to burn patient.

    Action

    In March 2008, the firm planned to visit each consignee to install the new software version 01.05.02 and hand deliver letters, dated 02/20/2008, notifying consignees of the reason for the action. The old software version is 01.04.02. The software was upgraded because the Ultrasound Core heats very quickly and if removed from the DDC while operating it may result in burns to the patient or user. The software will turn off the Ultrasound Core automatically if removed from the DDC during operation, and will prompt to restart therapy if ultrasound is turned off during treatment. On 04/17/2008, the firm issued a new letter with the date of April 2008 informing customers of the issue. In addition the letter indicates that the corrective action, release of the new software is delayed to incorporate further changes, and that customers will be notified when the software is available for their unit. Customers are advised that the device is safe to use when operating according to the Instructions for Use. EKOS contact number 1-888-356-7435

    Distribution

    Products were distributed nationwide to hospitals.

    Quantity

    218 units