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.
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.
조치
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.
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).