SenTec recalls

3 official recalls and safety alerts involving SenTec since 2022-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with SenTec or the relevant agency.

  1. 2023-09-27
  2. US
    Drugs & medicalClass II

    SenTec AG recalls Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3…

    During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.

    FDA · DeviceSenTec AGUS Nationwide distribution.Official notice →
  3. 2023-06-28
  4. US
    Drugs & medicalClass II

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

    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.

    FDA · DeviceSenTec AGUS Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.Official notice →
  5. 2022-11-09
  6. US