SenTec AG Recall 87054
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).
SenTec AG Recall 87054 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1134-2021 |
| Event ID | 87054 |
| Event 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). |
| Product Type | Devices |
| Distribution | IL, PA, FL, NJ, GA, MA |
| Quantity | 15 devices |
| Recall Reason | Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards. |
| Device Classification | 20210224 |
| Device Code Info | Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date |
| Center Classification Date | 20210218 |
| Recall Initiation Date | 20201210 |
| Recalling Firm | SenTec AG |
| Initial Notification | Letter |
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