Z-0088-2017Class II

SDMS (SenTec Digital Monitoring System)

Name: Z-0088-2017 SDMS (SenTec Digital Monitoring System)
Creator: SenTec AG
Published: 2016-09-15
License: https://open.fda.gov/license/

Sentec AG / initiated 2016-09-15 / Terminated

FDA source

SenTec AG began a recall of SDMS (SenTec Digital Monitoring System) on 2016-09-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0088-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-15
Posted: 2016-10-17
Terminated: 2017-06-23
Recalling firm: Sentec AG
Product: SDMS (SenTec Digital Monitoring System)
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
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).
FDA 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 ([email protected]) or phone (636-343-0000).
Quantity in commerce: 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.
Product codes and lots: SN 306497 to SN 306571.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0088-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0088-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-17

Product code LKD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)