BEUDAMED
    FDA Recall Terminated

    PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.

    Recall: Z-0727-04 · Initiated February 27, 2004

    Recall

    Recall Number
    Z-0727-04
    Event Number
    28410
    Firm
    General Electric Medical Systems Information Technology
    FEI Number
    2124823
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 27, 2004
    Posted
    July 20, 2004
    Terminated
    November 17, 2005
    Address
    8200 W Tower Ave, Milwaukee, WI, 53223-3219

    Description

    PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.

    Reason

    Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.

    Action

    Consignees were notified via certified mail, return receipt requested, on Friday, February 27, 2004. GE Field service representatives will upgrade affected PatientNet Central Stations (RVS, IRVS, or Sitelink IRVS) to software version 2.01.

    Distribution

    Nationwide throughout the United States

    Quantity

    Undetermined a this time. 574 sofware units were distributed with ability to upgrade one or multiple devices.