Philips North America recalled 1,913,441 IntelliVue Patient Monitors on October 31, 2025. A potential issue causes the monitors to fail to alarm, posing serious risks to patient safety. Consumers and healthcare providers should stop using these devices 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 MX100, Product Number 867033, is part of a global recall affecting 1,913,441 units. These devices were distributed worldwide, including the United States and numerous other countries.
The recall stems from a potential issue where the monitors do not alarm, which can lead to undetected patient distress. This malfunction poses a serious risk to patient safety.
There have been no specific reported incidents or injuries attributed to this alarm failure at this time.
Patients and healthcare providers should immediately stop using the device. Follow the manufacturer's recall instructions and contact Philips North America for further guidance.
For more information, contact Philips North America at the provided website link for the recall details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0861-2026.
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