SenTec AG recalls SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive pati…

Recall date

December 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1134-2021

FDA classification

Class II

Brand / firm

SenTec AG

Sold / distributed

IL, PA, FL, NJ, GA, MA

Why it was recalled

Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).