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U.S. Department of Health and Human Services

Class 2 Device Recall VSign Sensor 2 (VSA/P/N)

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  Class 2 Device Recall VSign Sensor 2 (VSA/P/N) see related information
Date Initiated by Firm May 02, 2023
Date Posted June 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-1980-2023
Recall Event ID 92355
510(K)Number K041548  
Product Classification Monitor, carbon-dioxide, cutaneous - Product Code LKD
Product V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Code Information Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.
Recalling Firm/
Manufacturer		 SenTec AG
Ringstrasse 39
Therwil Switzerland
For Additional Information Contact Mr. Bob Cormier
877-425-8746
Manufacturer Reason
for Recall		 The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
FDA Determined
Cause 2		 Device Design
Action The recalling firm issued a recall letter dated 5/2/2023 via email on 5/2/2023. The letter explained the reason for recall also stating that the sensors pose no risk to patients but have a high chance of not functioning upon being connected to an SDM monitor. The recalling firm informed the consignee they want to replace the defective sensors. An RMA was enclosed to return the sensor and the shipping confirmation of its replacement.
Quantity in Commerce 11 in the U.S.
Distribution US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
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 INC.
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