Company: Philips North America Llc.
Date of Enforcement Report: 10/4/2024
Class II
PRODUCT
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.
Recall Number:
Z-0020-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Philips North America Llc
VOLUME OF PRODUCT IN COMMERCE:
153 units OUS
DISTRIBUTION:
Foreign Only: Denmark France Germany Japan United Kingdom
