Z-0088-2017 Class II Terminated
FDA device recall Z-0088-2017 was initiated by SenTec AG on September 15, 2016 and is designated Class II. 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 scr… The recall status is terminated (terminated June 23, 2017). Affected quantity: 75 (54 US; 21 =OUS).
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2016
- Initiation Date
- September 15, 2016
- Termination Date
- June 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 (54 US; 21 =OUS)
Product Description
SDMS (SenTec Digital Monitoring System)
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 Pattern
Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.
Code Information
SN 306497 to SN 306571.