SenTec AG Recalls
14 recalls on record · August 22, 2012 to September 27, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 27, 2023Medical DevicesFDA
SenTec AG recalls Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each packa
Hazard: 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.
June 28, 2023Medical DevicesFDA
SenTec AG recalls V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Hazard: 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.
November 9, 2022Medical DevicesFDA
SenTec AG recalls sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carb
Hazard: Weak skin adhesion.
February 24, 2021Medical DevicesFDA
SenTec AG recalls SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patie
Hazard: Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
August 14, 2019Medical DevicesFDA
SenTec AG recalls SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon di
Hazard: 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.
August 14, 2019Medical DevicesFDA
SenTec AG recalls SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitor
Hazard: 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.
August 14, 2019Medical DevicesFDA
SenTec AG recalls SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous,
Hazard: 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.
August 14, 2019Medical DevicesFDA
SenTec AG recalls SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous,
Hazard: 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.
August 14, 2019Medical DevicesFDA
SenTec AG recalls SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of ca
Hazard: 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.
October 26, 2016Medical DevicesFDA
SenTec AG recalls SDMS (SenTec Digital Monitoring System)
Hazard: Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).
April 29, 2015Medical DevicesFDA
SenTec AG recalls Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. T
Hazard: SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens
November 28, 2012Medical DevicesFDA
Sentec AG recalls SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for us
Hazard: A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
November 28, 2012Medical DevicesFDA
Sentec AG recalls SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Si
Hazard: A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
August 22, 2012Medical DevicesFDA
Sentec AG recalls SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-tim
Hazard: SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.