SDMS (SenTec Digital Monitoring System) recall
SDMS (SenTec Digital Monitoring System)
Why was SDMS (SenTec Digital Monitoring System) 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SN 306497 to SN 306571.
- Product
- SDMS (SenTec Digital Monitoring System)
- Recalling firm
- SenTec AG
- 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.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)