Reported Apr 29, 2015 · Terminated
Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland.…
SenTec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SenTec AG · Ringstrasse 39 · 4106 Therwil · N/A
Is this the product you have?
- 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).
- Lot codes and dates
85 of 85 codes
315.105315.106315.107315.108315.109315.111315.112315.113315.114315.115315.116315.117315.118315.119315.120315.122315.123315.124315.125315.126315.127315.128315.285315.286315.287315.288315.289315.290315.291315.292315.294315.295315.296315.297315.298315.299315.300315.301315.302315.303315.305315.306315.307315.308315.309315.310315.311315.312315.313315.314315.275315.276315.277315.278315.279315.280315.281315.282315.283315.284
- Expanded
314.804314.813314.815314.820315.414315.415315.416315.417315.418315.419315.420315.421315.422315.423315.424315.425315.426315.427315.428315.429315.430315.431315.432315.433315.434315.435315.436315.437315.438315.439315.440315.441315.442315.443315.445315.446315.447315.448315.449315.450315.452315.453315.454315.455315.456315.457315.458315.459
- Amount recalled
- 129 US, 59 OUS
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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