Philips North America recalled 1,913,441 IntelliVue MP80 monitors on October 31, 2025. The devices may fail to alarm, presenting a high risk to patient safety. Healthcare providers and patients should 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 MP80, Product Number: M8008A. It was distributed worldwide, including the U.S. and multiple countries, since its release. Affected devices include all serial numbers of the model.
The IntelliVue MP80 monitors may not alarm when necessary. This failure can result in undetected health emergencies, posing a serious risk to patients.
There are no specific reported incidents or injuries related to this recall. However, the hazard level is classified as high due to the potential consequences of alarm failures.
Stop using the IntelliVue MP80 monitors immediately. Follow the recall instructions provided by Philips North America. Contact your healthcare provider for further instructions.
For more information, contact Philips North America at 1-800-XXX-XXXX. Visit the FDA recall notice for further details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0857-2026.
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