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U.S. Department of Health and Human Services

Class 2 Device Recall SenTec digital monitor

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  Class 2 Device Recall SenTec digital monitor see related information
Date Initiated by Firm December 10, 2020
Create Date February 18, 2021
Recall Status1 Open3, Classified
Recall Number Z-1134-2021
Recall Event ID 87054
510(K)Number K101690  K041548  K151329  
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
Product SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).
Code Information Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date
Recalling Firm/
Manufacturer		 SenTec AG
Ringstrasse 39
Therwil Switzerland
For Additional Information Contact Robert Cormier
877-425-8746 Ext. 100
Manufacturer Reason
for Recall		 Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
FDA Determined
Cause 2		 Device Design
Action The firm initiated their correction by letter to the direct accounts on 12/10/2020. The letter explains the problem and provides additional instruction manuals and a sticker to address the use of the product in the home care environment.
Quantity in Commerce 15 devices
Distribution IL, PA, FL, NJ, GA, MA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LKD and Original Applicant = SENTEC AG
510(K)s with Product Code = LKD and Original Applicant = SENTEC INC.
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