SDMS (SenTec Digital Monitoring System)
This recall has been terminated (originally issued October 17, 2016).
- Recall Initiated
- September 15, 2016
- Posted
- October 17, 2016
- Terminated
- June 23, 2017
- Recall Number
- Z-0088-2017
- Quantity
- 75 (54 US; 21 =OUS)
- Official Source
- View on FDA website ↗
Reason for Recall
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).
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.
Lot / Code Info
SN 306497 to SN 306571.
Root Cause
Component change control
Action Taken
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).