Recall Z-0088-2017— SenTec AG
Class II · Terminated
Class II FDA medical device recall by SenTec AG, initiated 2016-09-15, terminated 2017-06-23. It names 4 FDA 510(k) clearances: K151329, K101690, K071672 and 1 more. Product: SDMS (SenTec Digital Monitoring System). Reason: Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator)..
- Recalling firm
- SenTec AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-15
- Terminated
- 2017-06-23
- Firm location
- Therwil, N/A, Switzerland
510(k) clearances named in this recall
4 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
- K071672 — SENTEC DIGITAL MONITORING SYSTEM
- 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
SDMS (SenTec Digital Monitoring System)
Reason for recall
Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).
Data sourced from openFDA. This site is unofficial and independent of the FDA.