Events

Recall of Device Recall SenTec, VSign"2 Sensors

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sentec AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62589
  • Event Risk Class
    Class 2
  • Event Number
    Z-2199-2012
  • Event Initiated Date
    2012-07-09
  • Event Date Posted
    2012-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111100
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, carbon-dioxide, cutaneous - Product Code LKD
  • Reason
    Sentec is recalling a number of v-sign"2 sensors due to a problem regarding configuration parameter writing during manufacturing.
  • 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.

Device

Device Recall SenTec, VSign"2 Sensors
  • Model / Serial
    310701 311100 311239 310996 311920 311943 311958 312132
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
  • Product Description
    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).
  • Manufacturer
    Sentec AG

Manufacturer

Sentec AG
  • Manufacturer Address
    Sentec AG, Ringstrasse 39, Therwil, Baselland Switzerland
  • Manufacturer Parent Company (2017)
    Sentec Ag
  • Source
    USFDA