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 recalling a number of v-sign"2 sensors due to a problem regarding configuration parameter writing during manufacturing.
조치
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.
Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
제품 설명
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).