FDA Recall: After Recalibration, Sensors Stayed in Software Mode

Company: SenTec AG
Date of Enforcement Report: 06/20/2023
Class II

PRODUCT

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

Recall Number:

Z-1980-2023

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/MANUFACTURER:

SenTec AG

VOLUME OF PRODUCT IN COMMERCE:

11 in the U.S.

DISTRIBUTION:

US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

Upcoming Public Courses

No public courses are planned at this time.

If you would like to discuss a private, onsite course, please fill out the form below.

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.