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SenTec AG recalls SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patie
Recalled February 24, 2021 · FDA recall Z-1134-2021 · SenTec AG
Hazard
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. · FDA Class II
Units
15 devices
Sold at
IL, PA, FL, NJ, GA, MA
Description
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
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).
Manufacturer(s)
SenTec AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →