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
- M8004A, UDI-DI: 00884838000179
- 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 MP50 is a patient monitor used in clinical settings to track vital signs and alert clinicians to changes in patient status. It is part of Philips' monitoring portfolio used in hospitals and clinics.
Why This Is Dangerous
If the monitor fails to alarm, clinicians may miss early signs of patient deterioration, delaying treatment and increasing risk to patients.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals with MP50 monitors may need to halt use, perform asset tallies, and coordinate replacements or repairs as directed by Philips. The recall covers a large global footprint, indicating a substantial operational impact on health systems.
Practical Guidance
How to identify if yours is affected
- Confirm device model: IntelliVue MP50 with Product Number M8004A.
- Note that all serial numbers are included in this recall.
Where to find product info
Model number on the device label and packaging; recall notification letter from Philips.
What timeline to expect
The recall notice does not specify a timeline for replacement or repair.
If the manufacturer is unresponsive
- Document all contact attempts with Philips.
- Escalate to hospital administration and procurement.
- File a complaint with the FDA if Philips is unresponsive.
How to prevent similar issues
- Verify devices against recall lists before deployment.
- Maintain an up-to-date inventory of medical devices and serial numbers.
- Ensure a clear line of communication with the manufacturer for recalls.
Documentation advice
Keep the recall notice, device identifiers (model, UDI), and all correspondence with Philips. Record dates and outcomes of all actions.
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Product Details
Product: IntelliVue MP50 patient monitor. Model/Product Number: M8004A. UDI-DI: 00884838000179. Sold worldwide, including the United States. Recall date: 2025-10-31. Distributor/Manufacturer: Philips North America LLC. Quantity: 1,913,441 units. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,913,441 units affected worldwide
- Product Number M8004A; UDI-DI 00884838000179
- All serial numbers affected
- Recall notice issued by Philips North America LLC on 2025-10-31
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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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