Medical device recalls Moderate risk

Mindray DS USA, Inc. dba Mindray North America recalls Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for m…

Recall date
July 27, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2737-2015
FDA classification
Class II
Brand / firm
Mindray DS USA, Inc. dba Mindray North America
Sold / distributed
Distributed to the states of CT, IA, KY, MS, PA, UT and WA.

Why it was recalled

The DPM 7 Monitors may display a black screen.

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

What was recalled

Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.

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