Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2,…

Recall date
August 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0292-2018
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
Worldwide Distribution and US Nationwide

Why it was recalled

Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors

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

What was recalled

IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.

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