| Date Initiated by Firm |
March 25, 2015 |
| Date Posted |
April 22, 2015 |
| Recall Status1 |
Terminated 3 on February 05, 2016 |
| Recall Number |
Z-1501-2015 |
| Recall Event ID |
70878 |
| 510(K)Number |
K101690
|
| Product Classification |
Monitor, carbon-dioxide, cutaneous - Product Code LKD
|
| Product |
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).
|
| 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 |
Recalling Firm/
Manufacturer |
SenTec AG
Ringstrasse 39
4106 Therwil Switzerland
|
Manufacturer 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
|
FDA Determined
Cause 2 |
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 to be replaced. |
| Quantity in Commerce |
129 US, 59 OUS |
| Distribution |
US Distribution to the state of : MO |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = LKD and Original Applicant = SENTEC AG
|
