FDA-Device2021-06-02Class II
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Philips North America Llc
Hazard
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Sold states
Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Affected count
3 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1671-2021Don't want to check this manually?
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