Recall Z-2199-2012— Sentec AG
Class II · Terminated
Class II FDA medical device recall by Sentec AG, initiated 2012-07-09, terminated 2012-10-11. It names one FDA 510(k) clearance: K101690. Product: SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).. Reason: SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing..
- Recalling firm
- Sentec AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-09
- Terminated
- 2012-10-11
- Firm location
- Therwil, Baselland, Switzerland
510(k) clearances named in this recall
1 on FDA's record- K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
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, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
Reason for recall
SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.