Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered Recalled by Philips North America Llc Due to Devices with Option CP2 and initially programmed to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America Llc directly.
Affected Products
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Quantity: 153 units OUS
Why Was This Recalled?
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
Where Was This Sold?
Foreign Only: Denmark France Germany Japan United Kingdom
About Philips North America Llc
Philips North America Llc has 301 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report