Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. Th
FDA device recall Z-1501-2015 · posted 2015-04-22 · Terminated
Recall details
- Recalling firm
- SenTec AG
- 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
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LKD
- Quantity affected
- 129 US, 59 OUS
- Distribution
- US Distribution to the state of : MO
- Date initiated
- 2015-03-25
- Date posted
- 2015-04-22
- Date terminated
- 2016-02-05
- Location
- Therwil, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE (K101690) | Sentec AG | 2010-12-03 |