Recall Z-1980-2023— SenTec AG

Name: FDA recall Z-1980-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-02

Class II · Ongoing

Class II FDA medical device recall by SenTec AG, initiated 2023-05-02. It names one FDA 510(k) clearance: K041548. Product: V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).. Reason: The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode..

Recalling firm: SenTec AG
Classification: Class II
Status: Ongoing
Initiated: 2023-05-02
Firm location: Therwil, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K041548 — SENTEC DIGITAL MONITOR MODEL #SDMSentec, Inc.·cleared 2004-08-09

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

V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

Reason for recall

The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

Data sourced from openFDA. This site is unofficial and independent of the FDA.