Recall Z-2199-2012 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
Sentec AG
SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
| Date | Aug 13, 2012 (initiated Jul 9, 2012) |
| Status | Terminated |
| Reason | SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing. |
| Root cause | Device Design |
| Action | SenTec sent a Field Safety Notice dated July 12, 2012, via email to all affected customers. It identified the product the problem and the action needed to be taken by the customer. Customers were instructed the affected Sensors in the field must be replaced. Please locate the affected Sensors and return them to SenTec for analysis immediately. SenTec will provide you with replacement Sensors within the next three months.This notice needs to be passed on to all those who need to be aware within your organization. Please transfer this notice to other organizations on which this action has an |
| Quantity | 8 |
| Distribution | Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand. |
| 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 |