Philips North America recalled 1,913,441 IntelliVue MP5 monitors on October 31, 2025, due to a failure to alarm. The recall affects devices distributed worldwide, including the United States. Patients and healthcare providers must stop using the monitors immediately.
Potential issue where the IntelliVue monitors did not alarm.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the IntelliVue MP5, Product Number: M8105A. It has a UDI-DI of 00884838000230 and includes all serial numbers. The devices were distributed worldwide.
The IntelliVue MP5 monitors may fail to alarm, posing a significant risk to patient safety. The U.S. Food and Drug Administration classified this recall as Class II, indicating a potential for temporary or medically reversible adverse health consequences.
No specific reported incidents or injuries have been mentioned in the recall notice. The high hazard level suggests that the potential for serious consequences is significant.
Stop using the IntelliVue MP5 monitors immediately. Follow the manufacturer's instructions for returning the device. Contact Philips North America or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0850-2026 or call Philips North America.
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