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.
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.
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.
After recalibration, the sensors stay in a software mode called "production" instead of resetting to "released" mode. This can cause the sensors to fail immediately after being used, potentially preventing them from functioning correctly in the monitoring system.
Users of the Sentec Digital Monitoring System (model SDMS) with the V-Sign Sensor 2 component (REF VS-A/P/N) are affected. Those who have the specific serial numbers listed are most at risk.
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.
Verify if the sensor is in "released" mode by checking the software settings after recalibration.
The sensors may experience an out-of-box failure after recalibration because they stay in the software mode "production" instead of resetting to "released" mode.
The recall record does not specify a remedy, so no action is required unless the sensor fails to work after recalibration.
Check for serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997 or UDI-DI code 07640121880513.
We’ve drafted a message you can send SenTec to request your refund or repair — edit it as you like.
Subject: Recall Z-1980-2023 — SenTec SenTec Hello, I own a SenTec that is covered by recall Z-1980-2023 from SenTec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
