medical Class II Updated 2021-02-24

SenTec AG recalls SenTec Digital Monitor, Model SDM, is a portable stand-alone

Recalled 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).


Hazard / Issue

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

Issued by

FDA

Affected States: IL, PA, FL, NJ, GA, MA
Lot/Code Info: Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date
View official government recall

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