BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1980-2023 · Initiated May 2, 2023

    Recall

    Recall Number
    Z-1980-2023
    Event Number
    92355
    Firm
    SenTec AG Ringstrasse 39 Therwil Switzerland
    FEI Number
    3004149774
    Product Code
    LKD
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 2, 2023
    Posted
    June 20, 2023

    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.

    Action

    The recalling firm issued a recall letter dated 5/2/2023 via email on 5/2/2023. The letter explained the reason for recall also stating that the sensors pose no risk to patients but have a high chance of not functioning upon being connected to an SDM monitor. The recalling firm informed the consignee they want to replace the defective sensors. An RMA was enclosed to return the sensor and the shipping confirmation of its replacement.

    Distribution

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

    Quantity

    11 in the U.S.