Philips North America has recalled 153 IntelliVue Patient Monitors (models MX400, MX450, MX500, and MX550) that were manufactured with software version P.01.01 and ordered with Option CP2. These devices were configured incorrectly at the factory, resulting in the 'Enhanced ECG Capabilities' and 'Full Arrhythmia' features being disabled. Because of this defect, the monitors will not provide necessary yellow alarms for enhanced arrhythmia detection, which are critical for monitoring patient heart health. This recall is being reported retrospectively from June 2023.
If the enhanced arrhythmia detection alarms are not functioning, healthcare providers may not be alerted to dangerous changes in a patient's heart rhythm. This failure to notify staff of a medical emergency could result in a delay of critical treatment or life-threatening cardiac events.
Contact your healthcare provider or the manufacturer for further instructions and potential refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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