Home / Recalls / SenTec AG / Z-0088-2017

Z-0088-2017 Class II Terminated

Recalled by SenTec AG — Therwil, N/A

Recall Details

Product Type
Devices
Report Date
October 26, 2016
Initiation Date
September 15, 2016
Termination Date
June 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
75 (54 US; 21 =OUS)

Product Description

SDMS (SenTec Digital Monitoring System)

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).

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.

Code Information

SN 306497 to SN 306571.

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