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
- Product Number: M8003A, UDI-DI: 00884838000162, 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
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 MP40 is a patient monitoring device used in clinical settings to track vital signs and clinical status of patients.
Why This Is Dangerous
If the alarm function does not audible alert, clinicians may miss warning signs of patient deterioration, delaying response.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals must halt use of the affected monitors and coordinate with Philips for replacement or service to avoid potential delays in patient care.
Practical Guidance
How to identify if yours is affected
- 1. Check device label for Model M8003A.
- 3. Confirm serial numbers are included in the recall scope (All Serial No.).
Where to find product info
Recall documentation and identifiers appear on the device label, packaging, and the FDA recall page
What timeline to expect
Remedy actions, including replacement or service, will be coordinated by Philips. Expect a process that may span weeks.
If the manufacturer is unresponsive
- Document all contact attempts with Philips support.
- File a complaint with the FDA if Philips is unresponsive.
How to prevent similar issues
- Verify model numbers before installation of patient monitors.
- Maintain updated recall checks for critical medical devices.
- Ensure staff are trained to recognize alarm failures and report deviations.
Documentation advice
Save the recall notice, record device identifiers, and capture all correspondence with Philips for your records.
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Product Details
Model numbers: Product Number M8003A; UDI-DI: 00884838000162; All Serial No. sold worldwide. Sold in US nationwide and many other countries. Price: Not disclosed. Sold date: Not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US nationwide.
- Model: M8003A; UDI-DI: 00884838000162.
- Status: ACTIVE; Recall date: 2025-10-31; Report date: 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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