Quick Facts at a Glance
- Recall Date
- October 31, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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: 867033, UDI-DI: 00884838082595, All Serial No.
- Sold at
- Unknown
- 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 MX100 is a patient monitor used in clinical settings to track patient vital signs and display alerts.
Why This Is Dangerous
Failure to alarm could delay recognition of patient deterioration, potentially affecting patient safety.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
High-risk medical device issue with potential for delayed response in clinical care.
Practical Guidance
How to identify if yours is affected
- Check product number 867033 on the device label.
- Verify UDI-DI 00884838082595 via packaging or device label.
- Refer to FDA recall page for additional identifiers.
Where to find product info
FDA recall page and Philips recall notice; look for recall number Z-0861-2026.
What timeline to expect
No specific timeline provided; expect manufacturer communications for replacement or repair timelines.
If the manufacturer is unresponsive
- Escalate to hospital safety officer
- Contact FDA recall number for guidance
- Document attempts to contact manufacturer
How to prevent similar issues
- Verify alarm integrity on monitors periodically
- Maintain updated inventory of devices and serial numbers
- Train staff to recognize alarm failures and report promptly
Documentation advice
Keep recall notices, inventory lists, and correspondence with Philips.
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Product Details
Product: IntelliVue Patient Monitor MX100. Product Number: 867033. UDI-DI: 00884838082595. Quantity: 1,913,441 units. Distribution: Worldwide, with US nationwide and numerous other countries.
Reported Incidents
No specific incident counts are provided in the data set. You must assume potential clinical risk but the document does not cite confirmed injuries.
Key Facts
- Worldwide distribution including US and - Afghanistan to Zimbabwe
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Safety Guide
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