Z-2199-2012Class II

SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive...

Name: Z-2199-2012 SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive...
Creator: Sentec AG
Published: 2012-07-09
License: https://open.fda.gov/license/

Sentec AG / initiated 2012-07-09 / Terminated / root cause: design

FDA source

Sentec AG began a recall of SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and... on 2012-07-09. FDA classified it as Class II and gives the reason as "SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2199-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-09
Posted: 2012-08-13
Terminated: 2012-10-11
Recalling firm: Sentec AG
Product: SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
Reason for recall: SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
Root cause tag: design
FDA root cause: Device Design
Action: SenTec sent a Field Safety Notice dated July 12, 2012, via email to all affected customers. It identified the product the problem and the action needed to be taken by the customer. Customers were instructed the affected Sensors in the field must be replaced. Please locate the affected Sensors and return them to SenTec for analysis immediately. SenTec will provide you with replacement Sensors within the next three months.This notice needs to be passed on to all those who need to be aware within your organization. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Further questions please call (262 ) 594-2114.
Quantity in commerce: 8
Distribution: Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
Product codes and lots: 310701 311100 311239 310996 311920 311943 311958 312132

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2199-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2199-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-13

Product code LKD

K101690Class IISentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG / cleared 2010-12-03

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)