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
- M8008A
- 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 MP80 is a patient monitor used in hospitals to track vital signs. It plays a role in alerting clinicians to patient deterioration.
Why This Is Dangerous
If alarms fail to trigger, clinicians may miss critical signs of patient harm, delaying intervention.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may need to replace or service affected monitors, which could affect monitoring continuity and staffing coordination.
Practical Guidance
How to identify if yours is affected
- Identify devices by model M8008A and UDI 00884838000216
- Note that all serial numbers are affected as stated in the recall
- Cross-check with internal asset management lists for the MP80 family
Where to find product info
Refer to the FDA enforcement page and Philips recall notices for submission and replacement instructions
What timeline to expect
4-8 weeks for replacement or service arrangements
If the manufacturer is unresponsive
- Escalate to hospital risk management or biomedical engineering
- Document attempts to contact Philips and request escalation
How to prevent similar issues
- Test alarm functionality during commissioning of patient monitors
- Ensure firmware and alarm parameters are up to date
- Maintain an updated recall registry for critical devices
Documentation advice
Document device serials, purchase records, communications with Philips, and replacement status
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Product Details
Model numbers: M8008A. Sold worldwide to hospitals and healthcare providers. Sold from unknown date. Price unknown. Quantity recalled: 1,913,441 units. Countries distributed to: Worldwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model M8008A
- Worldwide distribution to hospitals and healthcare providers
- Status: ACTIVE as of 2025-12-10
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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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