Quick Facts at a Glance
- Recall Date
- October 31, 2025
- Hazard Level
- HIGH
- Brand
- Philips
- 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
- Product type
- Patient Monitor
- Model numbers
- Product Number: 866470, UDI-DI: 00884838070790, 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
April 18, 2026
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 MX850 is a patient monitor used in hospital settings to track vital signs and clinical data. It is designed for continuous observation of patients in acute care environments.
Why This Is Dangerous
If the device fails to alarm, clinicians may miss signs of patient deterioration, delaying critical interventions.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may need to halt use of affected units, replace equipment, and re-train staff to ensure monitoring continuity. Consumers could face treatment delays if devices are not returned promptly.
Practical Guidance
How to identify if yours is affected
- Check device Product Number: 866470
- Note that all serial numbers are affected
Where to find product info
Serial numbers and product identifiers are on the device label, packaging, and recall communications
What timeline to expect
4-8 weeks for refunds or replacements after approval
If the manufacturer is unresponsive
- File a formal complaint with the hospital risk management team
- Contact Philips North America LLC for escalation
- Consult FDA recall resources if the manufacturer is unresponsive
- Document all communications and retain copies
How to prevent similar issues
- Verify device recall status before shipment to care areas
- Maintain an up-to-date asset registry with model numbers and UDI codes
- Establish clear recall response procedures for medical devices
- Ask vendors for recall notification procedures during procurement
Documentation advice
Keep the recall letter, take photos of the device label, maintain a log of all communications and dates, store correspondence with Philips and the hospital.
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Product Details
Model numbers: Product Number 866470; UDI-DI 00884838070790. Sold worldwide; US nationwide and many countries listed in recall. Recall date: 2025-10-31. Quantity: 1,913,441 units. Price: Unknown. Serial numbers: All Serial No.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- All Serial Numbers affected
- Worldwide distribution including US
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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