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).
Reported: February 24, 2021 Initiated: December 10, 2020 #Z-1134-2021
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).
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.
Details
- Recalling Firm
- SenTec AG
- Units Affected
- 15 devices
- Distribution
- IL, PA, FL, NJ, GA, MA
- Location
- Therwil, N/A
Frequently Asked Questions
What product 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).. Recalled by SenTec AG. Units affected: 15 devices.
Why was this product recalled? ▼
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2021. Severity: Moderate. Recall number: Z-1134-2021.
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