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: 865241, UDI-DI: 00884838029088
- 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
March 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 MX700 is a hospital patient monitor used to continuously track vital signs and alert clinicians to patient status. It is part of Philips’ IntelliVue line of patient monitoring products.
Why This Is Dangerous
If the monitor does not alarm as intended, clinicians may miss warning signs of patient deterioration. This could delay intervention and impact patient safety.
Industry Context
This recall is not explicitly described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals must suspend use of the affected MX700 monitors and replace or repair per Philips guidance. The scale of nearly two million units implies large-scale operational disruption.
Practical Guidance
How to identify if yours is affected
- Verify model number 865241 on the device label.
- Check the UDI-DI 00884838029088 on the device documentation or label.
- Confirm serial numbers are not permitted for use as an exclusion or inclusion criterion since all serials are affected.
- Review Philips recall notice for detailed instructions.
Where to find product info
Recall notices, device labels, UDI-DI, and Philips instructions provide identification details.
What timeline to expect
Replacement or remedy timelines vary; hospital teams should expect several weeks for replacement units and onboarding.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Document all communications with Philips.
- Consider filing a formal complaint with the medical device sponsor if responses are delayed.
How to prevent similar issues
- Before purchasing monitors, verify alarm reliability and firmware update policies.
- Ask for documented recall histories and post-market surveillance data.
- Ensure alarm redundancy and escalation protocols are in place in clinical settings.
Documentation advice
Keep the recall letter, device labels, UDI-DI, purchase receipts, communications with Philips, and replacement/repair records.
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Product Details
- Product: IntelliVue Patient Monitor MX700 - Product Number: 865241 - UDI-DI: 00884838029088 - Serial numbers: All Serial No. (all units affected) - Quantity: 1,913,441 units - Sold/distributed: Worldwide - Recall date: 2025-10-31 - Manufacturer: Philips North America LLC - Original price: Unknown
Key Facts
- Global distribution including US nationwide
- All serial numbers affected
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Safety Guide
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