SDMS recalled over fire hazard

Recall date

September 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SenTec AG recalls SDMS (SenTec Digital Monitoring System)

Recall number

Z-0088-2017

FDA classification

Class II

Brand / firm

SenTec AG

Sold / distributed

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

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SDMS (SenTec Digital Monitoring System)