V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Summary
The FDA issued a Class II for V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System ( by SenTec AG. Reason: The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset .
Details
Source
Device Recall
External ID
Z-1980-2023
Action Date
2023-06-28
Status
Ongoing
Category
device
Product Description
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Lot/Code Info: Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997, UDI-DI 07640121880513.
Quantity Affected: 11 in the U.S.
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.
Distribution
US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-02
Company
Therwil
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 246 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SenTec AG has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SenTec AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SenTec AG have FDA actions?
SenTec AG has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1980-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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