FDA Device recall Z-1134-2021
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of ca…
- FDA Device
- Class II
- terminated
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class II recall of SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of ca… by Sentec Ag, citing device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1134-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-10 |
| Published | 2021-02-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sentec Ag |
| Distribution | FL, GA, IL, MA, NJ, PA |
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
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Identifiers
| code_info | Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1134-2021%22
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