BEUDAMED
    FDA Enforcement Class II Terminated

    Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.

    Recall: Z-0666-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0666-2017
    Event ID
    75336
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hamilton Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2016
    Initiation Date
    September 26, 2016
    Classification Date
    November 28, 2016
    Termination Date
    March 8, 2017
    Address
    4990 Energy Way, Reno, NV, 89502-4123, United States

    Description

    Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.

    Reason

    Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.

    Code Info

    Serial Numbers between 2001 and 2103

    Distribution

    Nationwide Distribution

    Quantity

    44 units