BEUDAMED
    FDA Enforcement Class II Ongoing

    SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).

    Recall: Z-1134-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1134-2021
    Event ID
    87054
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SenTec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2021
    Initiation Date
    December 10, 2020
    Classification Date
    February 18, 2021
    Address
    Ringstrasse 39, N/A, Therwil, N/A, N/A, Switzerland

    Description

    SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).

    Reason

    Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

    Code Info

    Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date

    Distribution

    IL, PA, FL, NJ, GA, MA

    Quantity

    15 devices