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U.S. Department of Health and Human Services

Class 2 Device Recall SenTec, VSign"2 Sensors

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  Class 2 Device Recall SenTec, VSign"2 Sensors see related information
Date Initiated by Firm July 09, 2012
Date Posted August 13, 2012
Recall Status1 Terminated 3 on October 11, 2012
Recall Number Z-2199-2012
Recall Event ID 62589
510(K)Number K101690  
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
Product 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).
Code Information 310701 311100 311239 310996 311920 311943 311958 312132
Recalling Firm/
Manufacturer		 Sentec AG
Ringstrasse 39
Therwil, Baselland Switzerland
For Additional Information Contact
262-594-2114
Manufacturer Reason
for Recall		 SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 8
Distribution Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LKD and Original Applicant = SENTEC AG
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