Events

Recall of Device Recall SenTec Digital Monitoring System (SDMS)

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
    70878
  • Event Risk Class
    Class 2
  • Event Number
    Z-1501-2015
  • Event Initiated Date
    2015-03-25
  • Event Date Posted
    2015-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135392
  • 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 voluntarily replacing v-sign sensors 2 due to pre-mature deterioration of a part of the pco2 measuring unit and thus disabling pco2-monitoring. this means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. there is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens.
  • Action
    Sentec sent an Important Information letter via email dated March 25, 2015. The letter described the problem and the product involved in the recall. Customers were instructed to locate the affected sensors at their end-customers and replace them with the new sensors. Replaced sensors are to be returned to SenTec. For questions contact SenTec at + 41 61 726 97 60. Consignee was sent an emai in regard to the recall being expanded. The email was sent on May 08, 2014. The email informed the consignee of the additional lot being affected and provided a list of the serial number of V-Sign Sensors to be replaced.

Device

Device Recall SenTec Digital Monitoring System (SDMS)
  • Model / Serial
    315.105  315.106 315.107  315.108  315.109  315.111  315.112  315.113  315.114  315.115  315.116  315.117  315.118  315.119  315.120  315.122  315.123  315.124  315.125  315.126  315.127  315.128  315.285  315.286  315.287  315.288  315.289  315.290  315.291  315.292  315.294  315.295  315.296  315.297  315.298  315.299  315.300  315.301  315.302  315.303  315.305  315.306  315.307  315.308  315.309  315.310  315.311  315.312 315.313  315.314  315.275  315.276  315.277 315.278 315.279  315.280  315.281  315.282  315.283  315.284  315.597  315.599   315.600  315.601 315.602  315.603  315.604  315.605  315.606  315.607  315.610  315.611  315.561  315.562  315.563  315.564 315.565 315.566  315.567  315.568  315.569  315.571  315.572  315.573 315.574   Expanded:  314.804 314.813 314.815 314.820 315.414 315.415 315.416 315.417 315.418 315.419 315.420 315.421 315.422 315.423 315.424 315.425 315.426 315.427 315.428 315.429 315.430 315.431 315.432 315.433 315.434 315.435 315.436 315.437 315.438 315.439 315.440 315.441 315.442 315.443 315.445 315.446 315.447 315.448 315.449 315.450 315.452 315.453 315.454 315.455 315.456 315.457 315.458 315.459
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : MO
  • Product Description
    Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), || and pulse rate (PR).
  • Manufacturer
    SenTec AG

Manufacturer

SenTec AG
  • Manufacturer Address
    SenTec AG, Ringstrasse 39, 4106 Therwil Switzerland
  • Manufacturer Parent Company (2017)
    Sentec Ag
  • Source
    USFDA