Recall Z-1134-2021 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
SenTec AG
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).
| Date | Dec 10, 2020 |
| Status | Terminated |
| Reason | Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. |
| Root cause | Device Design |
| 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. |
| Quantity | 15 devices |
| Distribution | IL, PA, FL, NJ, GA, MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM Sentec, Inc., Aug 9, 2004 |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE Sentec AG, Dec 3, 2010 |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet Sentec AG, Dec 17, 2015 |