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    SDMS (SenTec Digital Monitoring System)

    FDA Recall
    Terminated ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·September 15, 2016

    Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR).

    FDA Recall
    Terminated ·SenTec AG Ringstrasse·Product code LKD·March 25, 2015

    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Recall
    Terminated ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·May 2, 2019

    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·August 22, 2022

    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).

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·December 10, 2020

    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

    FDA Recall
    Terminated ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·May 2, 2019

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

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·May 2, 2023

    SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Recall
    Terminated ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·May 2, 2019

    SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Recall
    Terminated ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·May 2, 2019

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·July 25, 2023

    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Recall
    Terminated ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·May 2, 2019

    SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

    FDA Recall
    Terminated ·Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland·Product code LKD·July 9, 2012

    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.

    FDA Recall
    Terminated ·Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland·Product code LKD·November 5, 2012

    SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.

    FDA Recall
    Terminated ·Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland·Product code LKD·November 5, 2012