SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time mo
FDA device recall Z-2199-2012 · posted 2012-08-13 · Terminated
Recall details
- Recalling firm
- Sentec AG
- Reason for recall
- SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
- Action taken
- 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 impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Further questions please call (262 ) 594-2114.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LKD
- Quantity affected
- 8
- Distribution
- Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
- Date initiated
- 2012-07-09
- Date posted
- 2012-08-13
- Date terminated
- 2012-10-11
- Location
- Therwil, Baselland, 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 |