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Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, T...

FDA Device Recall #Z-1501-2015 — Class II — March 25, 2015

Recall Summary

Recall Number Z-1501-2015
Classification Class II — Moderate risk
Date Initiated March 25, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SenTec AG
Location 4106 Therwil
Product Type Devices
Quantity 129 US, 59 OUS

Product Description

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).

Reason for Recall

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

Distribution Pattern

US Distribution to the state of : MO

Lot / Code Information

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

Other Recalls from SenTec AG

Recall # Classification Product Date
Z-2592-2023 Class II Membrane Changer Single-Use, REF MC, each packa... Jul 25, 2023
Z-1980-2023 Class II V-Sign Sensor 2, REF VS-A/P/N, a component of S... May 2, 2023
Z-0148-2023 Class II sentec 24 / MARe-SF Multi-Site Attachment Ring ... Aug 22, 2022
Z-1134-2021 Class II SenTec Digital Monitor, Model SDM, is a portabl... Dec 10, 2020
Z-2156-2019 Class II SenTec Membrane Changer Insert [5 pcs - Product... May 2, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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