BEUDAMED
    FDA Enforcement Class II Terminated

    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.

    Recall: Z-0170-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0170-2014
    Event ID
    66408
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hamilton Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    September 26, 2013
    Classification Date
    November 6, 2013
    Termination Date
    March 29, 2018
    Address
    4990 Energy Way, N/A, Reno, NV, 89502-4123, United States

    Description

    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.

    Reason

    Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.

    Code Info

    Hamilton-C2; Serial numbers from 1000-7100.

    Distribution

    Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI.

    Quantity

    316 devices distributed in the US.