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).
Recall
- Recall Number
- Z-1134-2021
- Event Number
- 87054
- Firm
- SenTec AG Ringstrasse 39 Therwil Switzerland
- FEI Number
- 3004149774
- Product Code
- LKD
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 10, 2020
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).
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
The firm initiated their correction by letter to the direct accounts on 12/10/2020. The letter explains the problem and provides additional instruction manuals and a sticker to address the use of the product in the home care environment.
IL, PA, FL, NJ, GA, MA
15 devices