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Membrane Changer (single-use) / single unit MCRecalls & reported problems

SenTec AG · The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

13 other recalls cover devices cleared under the same FDA submission (K041548, K071672, K101690, K151329); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Jul 25, 2023Open, Classified

    During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.

    Z-2592-2023 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041548, K071672, K101690, K151329. One submission often covers many models, so check the product and lot details in each record.

  • Z-1980-2023 · May 2, 2023 · Open, Classified
    V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
  • Z-0148-2023 · Aug 22, 2022 · Terminated
    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
  • Z-1134-2021 · Dec 10, 2020 · Terminated
    SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxy
  • Z-2152-2019 · May 2, 2019 · Terminated
    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 sa
  • Z-2154-2019 · May 2, 2019 · Terminated
    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 oxyge
  • Z-2153-2019 · May 2, 2019 · Terminated
    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 oxyge
  • Z-2155-2019 · May 2, 2019 · Terminated
    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
  • Z-2156-2019 · May 2, 2019 · Terminated
    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 saturatio
  • Z-0088-2017 · Sep 15, 2016 · Terminated
    SDMS (SenTec Digital Monitoring System)
  • Z-1501-2015 · Mar 25, 2015 · Terminated
    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 conti
  • Z-0433-2013 · Nov 5, 2012 · Terminated
    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
  • Z-0434-2013 · Nov 5, 2012 · Terminated
    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
  • Z-2199-2012 · Jul 9, 2012 · Terminated
    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).

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