BEUDAMED
    FDA Enforcement Class I Ongoing

    Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

    Recall: Z-2526-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2526-2023
    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-T1, REF: 161006, Intensive Care and Transport 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: 07630002801850 & 07630002813532 / Affected Serial Numbers: 15929 17600 17661 17677 17698 17699 17741 17850 17877 17913 17925 17955 17957 17969 17975 17976 17982 17985 17986 17991 17993 17995 18009 18166 18183 18189 18191 18199 18224 18244 18251 18255 18256 18260 18263 18272 18273 18276 18288 18289 18305 18308 18333 18340 18349 18360 18363 18377 18378 18383 18414 18415 18419 18441 18451 18458 18461 18502 18537 18544 18550 18778 18784 19237 19290 19291 19292 19293 19294 19298 19304 19305 19470 19483 19490 26117

    Distribution

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

    Quantity

    76 units