FDAFDA · Food and drugs·Recall number Z-0088-2017
SDMS (SenTec Digital Monitoring System)
Published October 26, 2016 · Recall initiated: September 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SenTec AG
- Distributor
- 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
- SN 306497 to SN 306571.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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