Reported Oct 26, 2016 · Terminated
SDMS (SenTec Digital Monitoring System)
SenTec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SenTec AG · Ringstrasse 39 · Therwil, N/A · N/A
Is this the product you have?
- SDMS (SenTec Digital Monitoring System)
- Lot codes and dates
- SN 306497 to SN 306571.
- Amount recalled
- 75 (54 US; 21 =OUS)
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new SenTec AG recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.