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U.S. Department of Health and Human Services

Class 2 Device Recall SDMS (SenTec Digital Monitoring System)

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 Class 2 Device Recall SDMS (SenTec Digital Monitoring System)see related information
Date Initiated by FirmSeptember 15, 2016
Date PostedOctober 17, 2016
Recall Status1 Terminated 3 on June 23, 2017
Recall NumberZ-0088-2017
Recall Event ID 75257
510(K)NumberK041548 K071672 K101690 K151329 
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
ProductSDMS (SenTec Digital Monitoring System)
Code Information SN 306497 to SN 306571.
Recalling Firm/
Manufacturer		 SenTec AG
Ringstrasse 39
Therwil Switzerland
For Additional Information ContactSenTec represenatative
262-594-2114
Manufacturer Reason
for Recall		Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).
FDA Determined
Cause 2		Component change control
ActionDistributors were sent via e-mail a SenTec 'Mandatory initiated field correction action" letter dated September 15, 2016 . The letter provided a "Description of the issue, Affected products, Identify and localize affected products, Removal from use, Replacement of affected products at end customer & distributor / sub-distributor level". It also provided "action information for sub-distributors and affiliates, and end customers". For questions contact SenTec Inc. by e-mail (customersevice.usa@sentec.com) or phone (636-343-0000).
Quantity in Commerce75 (54 US; 21 =OUS)
DistributionWorldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LKD
510(K)s with Product Code = LKD
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