Recall Z-0088-2017 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
SenTec AG
SDMS (SenTec Digital Monitoring System)
| Date | Oct 17, 2016 (initiated Sep 15, 2016) |
| Status | Terminated |
| Reason | Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator). |
| Root cause | Component change control |
| Action | Distributors were sent via e-mail a SenTec 'Mandatory initiated field correction action" letter dated September 15, 2016 . The letter provided a "Description of the issue, Affected products, Identify and localize affected products, Removal from use, Replacement of affected products at end customer & distributor / sub-distributor level". It also provided "action information for sub-distributors and affiliates, and end customers". For questions contact SenTec Inc. by e-mail (customersevice.usa@sentec.com) or phone (636-343-0000). |
| Quantity | 75 (54 US; 21 =OUS) |
| Distribution | Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM Sentec, Inc., Aug 9, 2004 |
| K071672 | SENTEC DIGITAL MONITORING SYSTEM Sentec AG, Sep 12, 2007 |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE Sentec AG, Dec 3, 2010 |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet Sentec AG, Dec 17, 2015 |