Lower risk Medical device recall · FDA · Published May 2, 2023

SenTec V-Sign Sensor 2 Recall: Out-of-Box Failure After Recalibration

SenTec recalls V-Sign Sensor 2 (REF VS-A/P/N) due to potential out-of-box failure after recalibration. Affected units have specific serial numbers and UDI-DI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1980-2023Medical device SenTec ›

Lower-risk 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.

Take action

Contact the company

Recalling firmSenTec AGRingstrasse 39 · Therwil, Switzerland

✎ GovInfoNow plain-language explainer

SenTec is recalling V-Sign Sensor 2 components (REF VS-A/P/N) because they may fail out of the box after recalibration. This could prevent the sensors from working properly in the Sentec Digital Monitoring System. Read more at govinfonow.com/recall/58480-sentec-v-sign-sensor-2-recall-out-of-box-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/58480-sentec-v-sign-sensor-2-recall-out-of-box-failure · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1980-2023

Cite this page

“SenTec V-Sign Sensor 2 Recall: Out-of-Box Failure After Recalibration.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/58480-sentec-v-sign-sensor-2-recall-out-of-box-failure. Based on FDA recall #Z-1980-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1980-2023%22&limit=1).

SenTec AG voluntarily recalled V-Sign Sensor 2 components, part of the Sentec Digital Monitoring System, due to potential out-of-box failure. The Food and Drug Administration announced the Class II recall on May 2, 2023.

How to tell if you have it

Brand: SenTec
Product: V-Sign Sensor 2, REF VS-A/P/N
Component of: Sentec Digital Monitoring System (model SDMS)
Serial numbers: 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997
UDI-DI: 07640121880513

The hazard

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.

Context

GovInfoNow's records show SenTec AG has four other recalls on record since May 2, 2019. Other recent recalls include a July 25, 2023 recall of the SenTec Membrane Changer for manufacturing defects and an Aug. 22, 2022 recall of the SenT:24/MARe-SF Ring for weak skin adhesion.

How to tell if you have this one

Check for serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997 or UDI-DI code 07640121880513 on the V-Sign Sensor 2 component.

Brand
SenTec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Sensor Status
Verify if the sensor is in "released" mode by checking the software settings after recalibration.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 8 states.

FDA distribution: “US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Illinois, Massachusetts, Mississippi, Montana, Nevada, Texas.

Recall timeline

FDA published this recall 57 days after the firm started it.

May 2, 2023Firm started the recall
Jun 20, 2023FDA classified it Class II
Jun 28, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58480-sentec-v-sign-sensor-2-recall-out-of-box-failure">SenTec V-Sign Sensor 2 Recall: Out-of-Box Failure After Recalibration (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1980-2023 (May 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1980-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.