BEUDAMED
    FDA Recall Terminated

    Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.

    Recall: Z-1295-2015 · Initiated February 17, 2015

    Recall

    Recall Number
    Z-1295-2015
    Event Number
    70647
    Firm
    Transonic Systems Inc 34 Dutch Mill Rd Warren Road Business Park Ithaca NY 14850-9785
    FEI Number
    1319030
    Product Code
    MQS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 17, 2015
    Posted
    March 18, 2015
    Terminated
    May 31, 2016

    Description

    Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.

    Reason

    Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).

    Action

    Transonic sent a Medical Device Recall Letters and Response Forms dated February 17, 2015 to the users via e-mail and fax. The recall is being conducted to the user level. The letter identified the affected product, problem and actions to be taken. For questions call 607-257-5300 ext. 326.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea

    Quantity

    Domestic: 21 units, Foreign: 10 units