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: 866064, UDI-DI: 00884838038776, 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 is used in healthcare settings to monitor patients' vital signs. These monitors provide critical alerts for any changes in a patient's condition.
Why This Is Dangerous
The failure of the monitor to alarm poses a serious risk, as it may lead to undetected medical emergencies. This lack of signaling can prevent timely intervention by healthcare professionals.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a significant number of devices, which may leave healthcare providers without reliable monitoring tools, thus posing a risk to patient safety.
Practical Guidance
How to identify if yours is affected
- Verify the product number on the device is 866064.
- Check for the UDI-DI code 00884838038776 on the packaging or device.
- Look for any recall notifications or letters from Philips.
Where to find product info
Product numbers and UDI codes are typically found on the back or bottom of the monitor.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-8 weeks.
If the manufacturer is unresponsive
- Document your communications with Philips.
- Contact your healthcare provider for further advice.
- Consider filing a complaint with the CPSC if unresponsive.
How to prevent similar issues
- Ensure medical devices have reliable alarm systems before purchase.
- Research current recalls and safety alerts for medical devices.
- Choose manufacturers with a strong safety record.
Documentation advice
Keep records of all communications with Philips, including dates, times, and names of representatives.
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Product Details
The recall involves IntelliVue Patient Monitor MX500, product number 866064. It was distributed worldwide, including the U.S. and several other countries. The monitors were sold through multiple retailers.
Key Facts
- Class II recall affecting 1,913,441 units
- Potential alarm failure hazard
- Immediate stop-use instructions issued
- Worldwide distribution including the U.S.
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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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