SenTec AG: Medical Device Recall in 2016 - (Recall #: Z-0088-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

SDMS (SenTec Digital Monitoring System)

Product Classification:

Class II

Date Initiated: September 15, 2016

Date Posted: October 26, 2016

Recall Number: Z-0088-2017

Event ID: 75257

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).

Status: Terminated

Product Quantity: 75 (54 US; 21 =OUS)

Code Information:

SN 306497 to SN 306571.

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.

Voluntary or Mandated:

Voluntary: Firm initiated