Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil,…
Medical device recall Z-1501-2015. Published in FDA’s Enforcement Report on Apr 29, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 29, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Missouri the one state its words name
- 129 US, 59 OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR).
129 US, 59 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
315.105 315.106 315.107 315.108 315.109 315.111 315.112 315.113 315.114 315.115 315.116 315.117 315.118 315.119 315.120 315.122 315.123 315.124 315.125 315.126 315.127 315.128 315.285 315.286 315.287 315.288 315.289 315.290 315.291 315.292…
Every code shown here, 1,073 characters
315.105 315.106 315.107 315.108 315.109 315.111 315.112 315.113 315.114 315.115 315.116 315.117 315.118 315.119 315.120 315.122 315.123 315.124 315.125 315.126 315.127 315.128 315.285 315.286 315.287 315.288 315.289 315.290 315.291 315.292 315.294 315.295 315.296 315.297 315.298 315.299 315.300 315.301 315.302 315.303 315.305 315.306 315.307 315.308 315.309 315.310 315.311 315.312 315.313 315.314 315.275 315.276 315.277 315.278 315.279 315.280 315.281 315.282 315.283 315.284 315.597 315.599 315.600 315.601 315.602 315.603 315.604 315.605 315.606 315.607 315.610 315.611 315.561 315.562 315.563 315.564 315.565 315.566 315.567 315.568 315.569 315.571 315.572 315.573 315.574 Expanded: 314.804 314.813 314.815 314.820 315.414 315.415 315.416 315.417 315.418 315.419 315.420 315.421 315.422 315.423 315.424 315.425 315.426 315.427 315.428 315.429 315.430 315.431 315.432 315.433 315.434 315.435 315.436 315.437 315.438 315.439 315.440 315.441 315.442 315.443 315.445 315.446 315.447 315.448 315.449 315.450 315.452 315.453 315.454 315.455 315.456 315.457 315.458 315.459
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Distribution to the state of : MO
The states and territories these words name
- Missouri
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 25, 2015.
- FDA classified it on Apr 22, 2015.
- FDA’s Enforcement Report published it on Apr 29, 2015.
- FDA terminated it on Feb 5, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- SenTec AG, of 4106 Therwil, Switzerland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.