FDA Medical Device Recalls (openFDA)
Sentec AG: 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).
- Recall number
- Z-2199-2012
- 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).
- Status
- Terminated
- Initiated
- 2012-07-09
- Posted
- 2012-08-13
- Terminated
- 2012-10-11
- Reason
- SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
- 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
- 8
- Distribution
- Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
- Lot, serial or model codes
- 310701 311100 311239 310996 311920 311943 311958 312132
- 510(k) numbers
- ["K101690"]
- PMA numbers
- not on file
- Product code
- LKD
- Firm FEI
- 3004149774
- Firm city
- Therwil
- Firm state
- Baselland
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28