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: M8010A, UDI-DI: 00884838000223, 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
December 17, 2025
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 MP90 is a patient monitor used in healthcare settings to track vital signs. Healthcare providers rely on these devices for continuous monitoring to ensure patient safety during treatment.
Why This Is Dangerous
The monitors may fail to produce alarms, which are critical for alerting healthcare staff to changes in a patient's condition. This malfunction can lead to serious health risks if unnoticed.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a significant number of healthcare facilities worldwide, threatening patient safety. Immediate action is necessary to prevent potential health emergencies.
Practical Guidance
How to identify if yours is affected
- Check the product number on the device to determine if it is M8010A.
- Verify the serial number against the list provided by Philips for affected units.
- Consult the recall notification letter for specific instructions.
Where to find product info
The product number and serial number are typically located on the back or bottom of the monitor.
What timeline to expect
Expect refund processing to take 4-8 weeks after returning the product.
If the manufacturer is unresponsive
- Document all correspondence related to the recall.
- Contact Philips again using different methods (phone, email).
- File a complaint with the FDA if the issue persists.
How to prevent similar issues
- When purchasing medical devices, ensure they have updated safety features.
- Check for active recalls on the FDA website before using any medical equipment.
- Consult healthcare professionals for recommendations on reliable medical devices.
Documentation advice
Keep a record of your purchase receipt, recall notification, and any communication with Philips regarding the recall.
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Product Details
The recalled product is the IntelliVue MP90, Product Number: M8010A. The recall affects 1,913,441 units distributed worldwide, including the U.S. and countries such as Canada, Australia, and the UK.
Key Facts
- Recall date: October 31, 2025
- Model: IntelliVue MP90, Product Number: M8010A
- Quantity recalled: 1,913,441 units
- Risk level: High due to potential alarm failure
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Safety Guide
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