SenTec AG: Medical Device Recall in 2021 - (Recall #: Z-1134-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: December 10, 2020

Date Posted: February 24, 2021

Recall Number: Z-1134-2021

Event ID: 87054

Reason for Recall:

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

Status: Ongoing

Product Quantity: 15 devices

Code Information:

Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date

Distribution Pattern:

IL, PA, FL, NJ, GA, MA

Voluntary or Mandated:

Voluntary: Firm initiated