BEUDAMED
    FDA Enforcement Class I Ongoing

    VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

    Recall: Z-1942-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-1942-2026
    Event ID
    98554
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ventec Life Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 13, 2026
    Initiation Date
    March 25, 2026
    Classification Date
    May 1, 2026
    Address
    22002 26th Ave Se, Bothell, WA, 98021-4903, United States

    Description

    VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

    Reason

    Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

    Code Info

    UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914, PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a "P" at the end): 152884, 152885, 152886, 152887, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532

    Distribution

    US: OH, GA, CA, MO

    Quantity

    42