Z-1980-2023Class II

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

Name: Z-1980-2023 V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS)
Creator: SenTec AG
Published: 2023-05-02
License: https://open.fda.gov/license/

Sentec AG / initiated 2023-05-02 / Open, Classified / root cause: design

FDA source

SenTec AG began a recall of V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS) on 2023-05-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1980-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-02
Posted: 2023-06-20
Recalling firm: Sentec AG
Product: V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 11 in the U.S.
Distribution: US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
Product codes and lots: Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1980-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1980-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-28	2023-06-20

Product code LKD

K041548Class IISentec Digital Monitor Model #SdmSentec, Inc. / cleared 2004-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)