Events

Recall of Device Recall VSign Membrane Changer

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
    63631
  • Event Risk Class
    Class 2
  • Event Number
    Z-0433-2013
  • Event Initiated Date
    2012-11-05
  • Event Date Posted
    2012-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114386
  • 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
    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.
  • Action
    SenTec notified the one US distributor via e-mail on November 5, 2012. The distributor was advised to stop distribution of affected lot numbers. The communication to the distributor described the issue, identified affected product, and stated that SenTec will replace current stock at the end-customer level. The end user can discard the affected products. The distributor is asked to respond back with an e-mail to SenTec that they took appropriate action.

Device

Device Recall VSign Membrane Changer
  • Model / Serial
    Lot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in MO.
  • Product Description
    SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. || The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.
  • Manufacturer
    Sentec AG

Manufacturer

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