BEUDAMED
    FDA Enforcement Class II Terminated

    SDMS (SenTec Digital Monitoring System)

    Recall: Z-0088-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0088-2017
    Event ID
    75257
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SenTec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 26, 2016
    Initiation Date
    September 15, 2016
    Classification Date
    October 17, 2016
    Termination Date
    June 23, 2017
    Address
    Ringstrasse 39, N/A, Therwil, N/A, N/A, Switzerland

    Description

    SDMS (SenTec Digital Monitoring System)

    Reason

    Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).

    Code Info

    SN 306497 to SN 306571.

    Distribution

    Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.

    Quantity

    75 (54 US; 21 =OUS)