Recall Z-2592-2023— SenTec AG
Class II · Ongoing
Class II FDA medical device recall by SenTec AG, initiated 2023-07-25. It names 3 FDA 510(k) clearances: K151329, K101690, K041548. Product: Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).. Reason: During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance..
- Recalling firm
- SenTec AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-25
- Firm location
- Therwil, 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
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
Reason for recall
During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.