Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SenTec Digital Monitor Recalled by SenTec AG Due to Device requires the use of an Isolation Transformer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SenTec AG directly.
Affected Products
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).
Quantity: 15 devices
Why Was This Recalled?
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Where Was This Sold?
This product was distributed to 6 states: FL, GA, IL, MA, NJ, PA
About SenTec AG
SenTec AG has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report