Philips North America Llc is recalling 80 IntelliVue Patient Monitors (models MX400, MX450, MX500, and MX550) because they were shipped or upgraded with incorrect software versions. Software versions L.x and M.x (and some K.x versions) were accidentally stripped of critical monitoring capabilities like options M05, M06, and M20. This defect means the devices may not perform all intended monitoring functions, which could lead to incorrect or delayed treatment for patients in clinical settings. These monitors were distributed nationwide and internationally starting in June 2024.
Because specific software entitlements were removed, the monitors may fail to provide healthcare professionals with essential physiological data or alarms. This lack of information can result in medical staff missing critical changes in a patient's condition, potentially leading to delayed life-saving interventions.
Manufacturer correction/software entitlement update
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.
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Sources: FDA iRES · Raw API Response
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