Therwil, N/A, Switzerland
SenTec AG recalls
5 recalls recorded since 2018, most recently on 25 July 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 July 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2592-2023
- 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
Ongoing Class II Medical devices
- Recall started
- 2 May 2023
- Reason
- The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1980-2023
- V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Terminated Class II Medical devices
- Recall started
- 22 August 2022
- Terminated
- 26 May 2026
- Reason
- Weak skin adhesion.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0148-2023
- sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
Terminated Class II Medical devices
- Recall started
- 10 December 2020
- Terminated
- 31 August 2026
- Reason
- Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
- Distribution
- IL, PA, FL, NJ, GA, MA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1134-2021
- 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 o
Terminated Class II Medical devices
- Recall started
- 2 May 2019
- Terminated
- 16 December 2020
- Reason
- There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
- Distribution
- Worldwide distribution - US Nationwide in the state of Missouri and countries of Argentina, Australia, Austria, Belgium, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Europe, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Israel, Italy, Kuwait, Malaysia, F
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2153-2019, Z-2152-2019, Z-2154-2019, Z-2155-2019, Z-2156-2019
- 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 a
- 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 ped
- 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 a
- 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 adul
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.