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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 monitorsee related information
Date Initiated by FirmDecember 10, 2020
Create DateFebruary 18, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1134-2021
Recall Event ID 87054
510(K)NumberK041548 K101690 K151329 
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
ProductSenTec 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 ContactRobert 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
ActionThe 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 Commerce15 devices
DistributionIL, PA, FL, NJ, GA, MA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LKD
510(K)s with Product Code = LKD
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