SenTec AG Ringstrasse 39 Therwil Switzerland 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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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).
Brand
SenTec AG Ringstrasse 39 Therwil Switzerland
Lot Codes / Batch Numbers
Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date
Products Sold
Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date
SenTec AG Ringstrasse 39 Therwil Switzerland is recalling SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuou due to Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Recommended Action
Per FDA guidance
The firm initiated their correction by letter to the direct accounts on 12/10/2020. The letter explains the problem and provides additional instruction manuals and a sticker to address the use of the product in the home care environment.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, IL, MA, NJ, PA
Page updated: Jan 10, 2026