RegWardenFDA facility compliance records
Facility

SENTEC, INC.

9 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 2 recalls; 2015: 1 recalls; 2016: 1 recalls; 2019: 1 recalls; 2020: 1 recalls; 2022: 1 recalls; 2023: 2 recalls2’12’13’141’151’16’17’181’191’20’211’222’23’24’25’26
  • Recalls (9)

Devices registered here (4)

  • Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
    Product code LPP (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2500
  • Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
    Product code KLK (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2500
  • Oximeter, Ear
    Product code DPZ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2710
  • Monitor, Carbon-Dioxide, Cutaneous
    Product code LKD (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.2480

Recalls & enforcement

  • Class IIOngoing2023-07-25
    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.
  • Class IIOngoing2023-05-02
    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.
  • Class IITerminated2022-08-22
    Weak skin adhesion.
  • Class IITerminated2020-12-10
    Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
  • Class IITerminated2019-05-02
    There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
  • Class IITerminated2016-09-15
    Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including …
  • Class IITerminated2015-03-25
    SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacemen…
  • Class IITerminated2012-11-05
    A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
  • Class IITerminated2012-07-09
    SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SENTEC, INC. (FEI 3012409105) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012409105-sentec-inc/

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