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).
FDA Recall Z-1134-2021 · Posted None
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Recalling FirmSenTec AG
Recall StatusTerminated
Product CodeLKD
Date Initiated2020-12-10
Date Terminated2026-08-31
Product Quantity15 devices
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
IL, PA, FL, NJ, GA, MA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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