Quick Facts at a Glance
- Recall Date
- October 31, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips North America
- Product type
- Patient Monitor
- Model numbers
- Product Number: 865240, UDI-DI: 00884838020733, All Serial No.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 31, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential issue where the IntelliVue monitors did not alarm.
What You Should Do
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
About This Product
The IntelliVue Patient Monitor MX800 is a medical device used in healthcare facilities to continuously monitor patients' vital signs. Healthcare providers rely on its alarm system to alert them to potential changes in a patient's condition.
Why This Is Dangerous
The primary hazard is the failure of the monitor's alarm system, which may not alert healthcare providers in critical situations. This can lead to undetected deterioration of a patient's health status.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The lack of functioning alarms poses a serious risk to patient safety, particularly in emergency and intensive care settings, leading to potential undetected health issues.
Practical Guidance
How to identify if yours is affected
- Locate the product number on the monitor to confirm it is Product Number: 865240.
- Check the serial number against the recall list if available.
- If unsure, contact Philips customer service for verification.
Where to find product info
The product number and serial number are typically found on the back or bottom of the monitor.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Consider contacting the FDA for further assistance.
- Keep records of the device's purchase and recall notice.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Ensure that medical devices are from reputable manufacturers with good safety records.
- Regularly verify that devices have been maintained according to manufacturer guidelines.
Documentation advice
Keep copies of any correspondence with Philips, along with receipts and proof of purchase for your records.
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Product Details
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.
Key Facts
- Failure to alarm may endanger patients
- Distributors worldwide including the US
- Immediate cessation of use advised
- Affected model: IntelliVue Patient Monitor MX800
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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