BEUDAMED
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    Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code LKD·November 19, 2009

    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

    Spanish 100-120V TCOM-860, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code LKD·November 19, 2009

    Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code LKD·July 16, 2015

    SDMS (SenTec Digital Monitoring System)

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

    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, 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 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 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

    French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code LKD·November 19, 2009

    TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.

    FDA Recall
    Terminated ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code LKD·February 20, 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

    TCM CombiM Modules 903-111

    FDA Recall
    Terminated ·Radiometer America Inc·Product code LKD·November 18, 2015

    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

    Transcutaneous C02 & 02 Monitor - 860, Refurbished, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code LKD·November 19, 2009