Philips North America recalled 1,913,441 IntelliVue MX100 patient monitors due to potential alarm failure. The recall is active as of December 2025. The manufacturer warns patients and healthcare providers to stop using affected devices and follow recall instructions. Contact Philips North America LLC for guidance.
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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IntelliVue MX100 is a patient monitor used in clinical settings to track patient vital signs and display alerts.
Failure to alarm could delay recognition of patient deterioration, potentially affecting patient safety.
This recall is not indicated as part of a broader industry pattern in the provided data.
High-risk medical device issue with potential for delayed response in clinical care.
FDA recall page and Philips recall notice; look for recall number Z-0861-2026.
No specific timeline provided; expect manufacturer communications for replacement or repair timelines.
Keep recall notices, inventory lists, and correspondence with Philips.
Product: IntelliVue Patient Monitor MX100. Product Number: 867033. UDI-DI: 00884838082595. Quantity: 1,913,441 units. Distribution: Worldwide, with US nationwide and numerous other countries.
No specific incident counts are provided in the data set. You must assume potential clinical risk but the document does not cite confirmed injuries.
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