BEUDAMED
    FDA Enforcement Class I Ongoing

    VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002

    Recall: Z-1196-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1196-2025
    Event ID
    96136
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ventec Life Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2025
    Initiation Date
    February 3, 2025
    Classification Date
    February 26, 2025
    Address
    22002 26th Ave Se, N/A, Bothell, WA, 98021-4903, United States

    Description

    VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002

    Reason

    Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

    Code Info

    REF/UDI-DI/Serial Numbers: PRT-00490-001/00855573007792/123627, 121892, 119639; PRT-01185-000/00855573007877/5038421, 116700, 117933, 5038112, 5038619, 5038717, 5038953, 5039086, 5039091, 5039361, 5039499, 5039503, 5039541, 5039636, 5039938, 5040019, 5040640, 5040762, 5041060, 5041078, 5041534, 5042558, 117344, 118464, 118509, 5039387; PRT-01185-002/00850018761154/5037655

    Distribution

    US distribution in CA, NY, and MO.

    Quantity

    30