FDA-Device2024-10-02Class II
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Philips North America
Hazard
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.
Sold states
US Nationwide. Global Distribution.
Affected count
545 devices
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3249-2024Don't want to check this manually?
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