SenTec AG: Medical Device Recall in 2023 - (Recall #: Z-1980-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 2, 2023

Date Posted: June 28, 2023

Recall Number: Z-1980-2023

Event ID: 92355

Reason for 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.

Status: Ongoing

Product Quantity: 11 in the U.S.

Code Information:

Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated