Medical device recalls Moderate risk

Philips North America recalls IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500…

Recall date
August 30, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3249-2024
FDA classification
Class II
Brand / firm
Philips North America
Sold / distributed
US Nationwide. Global Distribution.

Why it was recalled

During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.

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 Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)

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