Terminated

SDMS (SenTec Digital Monitoring System)

FDA Recall Z-0088-2017 · Posted 2016-10-17

Recalling FirmSenTec AG

Recall StatusTerminated

Product CodeLKD

Date Initiated2016-09-15

Date Terminated2017-06-23

Product Quantity75 (54 US; 21 =OUS)

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).

Firm 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).

Root Cause

Component change control

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLESentec AG · 2010-12-03 K071672SENTEC DIGITAL MONITORING SYSTEMSentec AG · 2007-09-12 K041548SENTEC DIGITAL MONITOR MODEL #SDMSentec, Inc. · 2004-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.