Mindray DS USA, Inc. dba Mindray North America product recalled over fire hazard

Recall date

April 28, 2017

Source

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

Official notice title

Mindray DS USA, Inc. dba Mindray North America recalls TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarmi…

Recall number

Z-2634-2017

FDA classification

Class II

Brand / firm

Mindray DS USA, Inc. dba Mindray North America

Sold / distributed

US Nationwide Distribution

Why it was recalled

Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.

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

What was recalled

TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.