Philips North America recalled 1,913,441 IntelliVue Patient Monitors on October 31, 2025. The monitors may fail to alarm, posing a serious risk to patient safety. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
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 IntelliVue Patient Monitor MX800, Product Number: 865240, is part of a global recall affecting 1,913,441 units. These monitors were distributed in the United States and numerous countries worldwide. They are used in healthcare settings to monitor patients' vital signs.
The IntelliVue monitors may not sound alarms as intended, which can lead to unmonitored changes in a patient's condition. This malfunction poses a significant risk to patient safety, especially in critical care situations.
There have been no specific reports of injuries or deaths related to this recall. However, the potential failure of the alarm system poses a high risk to patient safety.
Stop using the IntelliVue Patient Monitor MX800 immediately. Follow the instructions provided by Philips North America for returning the device. For further assistance, contact your healthcare provider or Philips directly.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0869-2026. Philips North America's customer service can be reached for specific inquiries.
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