BEUDAMED
    FDA Enforcement Class II Ongoing

    V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

    Recall: Z-1980-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1980-2023
    Event ID
    92355
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SenTec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2023
    Initiation Date
    May 2, 2023
    Classification Date
    June 20, 2023
    Address
    Ringstrasse 39, Therwil, N/A, Switzerland

    Description

    V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

    Reason

    The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

    Code Info

    Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.

    Distribution

    US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.

    Quantity

    11 in the U.S.