BEUDAMED
    FDA Enforcement Class II Terminated

    Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.

    Recall: Z-2057-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2057-2015
    Event ID
    71234
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hamilton Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    March 24, 2015
    Classification Date
    July 24, 2015
    Termination Date
    December 23, 2015
    Address
    4990 Energy Way, N/A, Reno, NV, 89502-4123, United States

    Description

    Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.

    Reason

    Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.

    Code Info

    Software version 2.20 and 2.41,

    Distribution

    Nationwide Distribution

    Quantity

    248