V-Sign Sensor 2 recall: Software Issue
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Why was V-Sign Sensor 2 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.
- Product
- V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
- Recalling firm
- SenTec AG
- Quantity
- 11 in the U.S.
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
- Recall date
- June 28, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)