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 (IntelliVue MX600)
- Model numbers
- 865242, UDI-DI 00884838029095
- 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
IntelliVue MX600 is a patient monitoring system used in clinical settings to track vital signs. It is designed to alert clinicians to deteriorating patient conditions.
Why This Is Dangerous
The defect can cause monitors to fail to emit alarms when a patient’s condition requires attention, potentially delaying intervention.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinicians must stop using these devices and await replacement or repair instructions to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check Product Number 865242 on the device label.
- Check UDI-DI 00884838029095 on the label.
- Confirm the device is a MX600 model and was distributed by Philips.
Where to find product info
On device labels, packaging, and hospital asset records; recall communications from Philips.
What timeline to expect
Remedies are handled by Philips through replacement or repair channels; specific timelines are not provided in the notice.
If the manufacturer is unresponsive
- Escalate with the hospital risk management team.
- Contact Philips Customer Care for escalation.
- If needed, file a complaint with the FDA.
How to prevent similar issues
- Check recalls before deploying hospital devices.
- Verify model numbers and UDIs with the manufacturer.
- Maintain an up-to-date inventory of monitored devices and their recall status.
Documentation advice
Keep copies of the recall notice, all correspondence with Philips, and records of the affected device identifiers.
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Product Details
Model numbers: Product Number 865242; UDI-DI: 00884838029095; All Serial Nos. affected; Distribution: Worldwide including US nationwide and many countries; Sold quantities or price: Not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- All Serial Nos affected
- Worldwide distribution including US
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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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