BEUDAMED
    FDA Enforcement Class I Ongoing

    Hamilton-MR1, REF: 161010, Intensive Care Ventilator

    Recall: Z-2528-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2528-2023
    Event ID
    92873
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hamilton Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 27, 2023
    Initiation Date
    July 26, 2023
    Classification Date
    September 20, 2023
    Address
    4655 Aircenter Cir, Reno, NV, 89502-5948, United States

    Description

    Hamilton-MR1, REF: 161010, Intensive Care Ventilator

    Reason

    Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

    Code Info

    UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800

    Distribution

    Distribution US nationwide, including Puerto Rico. OUS: Not provided

    Quantity

    12 units