Membrane Changer Inserts MC-IRecalls & reported problems

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. How this data works · Data updated Oct 13, 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 · 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-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-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-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-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-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-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).