FDA Medical Device Recalls (openFDA)
SenTec AG: SDMS (SenTec Digital Monitoring System)
- Recall number
- Z-0088-2017
- Recalling firm
- SenTec AG
- Product
- SDMS (SenTec Digital Monitoring System)
- Status
- Terminated
- Initiated
- 2016-09-15
- Posted
- 2016-10-17
- Terminated
- 2017-06-23
- Reason
- 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).
- Root cause
- Component change control
- Action
- 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).
- 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.
- Lot, serial or model codes
- SN 306497 to SN 306571.
- 510(k) numbers
- ["K041548","K071672","K101690","K151329"]
- PMA numbers
- not on file
- Product code
- LKD
- Firm FEI
- 3004149774
- Firm city
- Therwil
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28