BEUDAMED
    FDA Enforcement Class II Terminated

    Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.

    Recall: Z-2795-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2795-2018
    Event ID
    80467
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hamilton Medical AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    March 9, 2018
    Classification Date
    August 13, 2018
    Termination Date
    March 18, 2019
    Address
    Via Crusch 8, Bonaduz, N/A, Switzerland

    Description

    Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.

    Reason

    An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.

    Code Info

    Serial Number: 12244, 12246, 12338, 12343, 12344, 12345, 12351, 12352, 12355, 12370, 12380, 12382, 12383, 12412, 12426, 12432

    Distribution

    US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.

    Quantity

    16 devices