Recall Z-1134-2021— SenTec AG
Class II · Ongoing
Class II FDA medical device recall by SenTec AG, initiated 2020-12-10. It names 3 FDA 510(k) clearances: K151329, K101690, K041548. 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..
- Recalling firm
- SenTec AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-12-10
- Firm location
- Therwil, N/A, Switzerland
510(k) clearances named in this recall
3 on FDA's record- K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
- K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
- K041548 — SENTEC DIGITAL MONITOR MODEL #SDM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.