SenTec AG Ringstrasse 39 Therwil Switzerland V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Brand
SenTec AG Ringstrasse 39 Therwil Switzerland
Lot Codes / Batch Numbers
Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.
Products Sold
Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.
SenTec AG Ringstrasse 39 Therwil Switzerland is recalling V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). due to The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm issued a recall letter dated 5/2/2023 via email on 5/2/2023. The letter explained the reason for recall also stating that the sensors pose no risk to patients but have a high chance of not functioning upon being connected to an SDM monitor. The recalling firm informed the consignee they want to replace the defective sensors. An RMA was enclosed to return the sensor and the shipping confirmation of its replacement.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026