01

Nov

2024

FDA Recall: Enhanced ECG Capabilities not Enabled in Devices with Option CP2

0

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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