BEUDAMED
    FDA Recall Open, Classified

    Hamilton-MR1, REF: 161010, Intensive Care Ventilator

    Recall: Z-2528-2023 · Initiated July 26, 2023

    Recall

    Recall Number
    Z-2528-2023
    Event Number
    92873
    Firm
    Hamilton Medical, Inc.
    FEI Number
    2937708
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 26, 2023
    Posted
    September 20, 2023
    Address
    4655 Aircenter Cir, Reno, NV, 89502-5948

    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.

    Action

    On July 26, 2023, Hamilton Medical issued Urgent Medical Device Correction via E-Mail. Hamilton Medical asked consignees to take the following actions 1. Check for affected devices in your facility. Get in contact with your local distribution partner and get the devices serviced with high priority. 2. Please sign the enclosed/attached sheet to confirm that, as an End- Customer, you have received and duly noted this Medical Device Correction.

    Distribution

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

    Quantity

    12 units