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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips Electronics North America Corporation: Five warning statements are missing from the instructions for use.

Agency Publication Date: June 11, 2018
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Affected Products

Product: IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350

All devices since release of B.05 (March 2016) prefix date code >/= US096

Product: IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351

All devices since release of B.05 (March 2016) prefix date code >/= US096

Product: IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352

All devices since release of B.05 (March 2016) prefix date code >/= US096

Product: IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146

All devices.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80064
Status: Resolved
Manufacturer: Philips Electronics North America Corporation
Manufactured In: United States
Units Affected: 4 products (25,499; 7,178; 4,488; 94)

Were You Affected by This Recall?

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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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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.