FDA recall Z-1134-2021

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).

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.

Distribution

IL, PA, FL, NJ, GA, MA

Key facts

Status

Ongoing

Initiation date

2020-12-10

Report date

2021-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Therwil, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2021