Date Initiated by Firm |
September 15, 2016 |
Date Posted |
October 17, 2016 |
Recall Status1 |
Terminated 3 on June 23, 2017 |
Recall Number |
Z-0088-2017 |
Recall Event ID |
75257 |
510(K)Number |
K041548 K101690 K151329 K071672
|
Product Classification |
Monitor, carbon-dioxide, cutaneous - Product Code LKD
|
Product |
SDMS (SenTec Digital Monitoring System) |
Code Information |
SN 306497 to SN 306571. |
Recalling Firm/ Manufacturer |
SenTec AG Ringstrasse 39 Therwil Switzerland
|
For Additional Information Contact |
SenTec 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 |
Action |
Distributors 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 Commerce |
75 (54 US; 21 =OUS) |
Distribution |
Worldwide 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 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 510(K)s with Product Code = LKD and Original Applicant = SENTEC INC.
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