BEUDAMED
    FDA Recall Terminated

    SDMS (SenTec Digital Monitoring System)

    Recall: Z-0088-2017 · Initiated September 15, 2016

    Recall

    Recall Number
    Z-0088-2017
    Event Number
    75257
    Firm
    SenTec AG Ringstrasse 39 Therwil Switzerland
    FEI Number
    3004149774
    Product Code
    LKD
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    September 15, 2016
    Posted
    October 17, 2016
    Terminated
    June 23, 2017

    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).

    Action

    Distributors were sent via e-mail a SenTec 'Mandatory initiated field correction action" letter dated September 15, 2016 . The letter provided a "Description of the issue, Affected products, Identify and localize affected products, Removal from use, Replacement of affected products at end customer & distributor / sub-distributor level". It also provided "action information for sub-distributors and affiliates, and end customers". For questions contact SenTec Inc. by e-mail ([email protected]) or phone (636-343-0000).

    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)