Recall Z-1501-2015 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
SenTec AG
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).
| Date | Apr 22, 2015 (initiated Mar 25, 2015) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | Sentec sent an Important Information letter via email dated March 25, 2015. The letter described the problem and the product involved in the recall. Customers were instructed to locate the affected sensors at their end-customers and replace them with the new sensors. Replaced sensors are to be returned to SenTec. For questions contact SenTec at + 41 61 726 97 60. Consignee was sent an emai in regard to the recall being expanded. The email was sent on May 08, 2014. The email informed the consignee of the additional lot being affected and provided a list of the serial number of V-Sign Sensors |
| Quantity | 129 US, 59 OUS |
| Distribution | US Distribution to the state of : MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE Sentec AG, Dec 3, 2010 |