Quick Facts at a Glance
- Recall Date
- October 31, 2025
- Hazard Level
- HIGH
- Brand
- Philips
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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: M8001A, UDI-DI: 00884838000193, 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
The IntelliVue MP20 is a hospital patient monitor used to track vital signs and alert clinicians to patient condition changes.
Why This Is Dangerous
A potential alarm failure could delay critical alarms, increasing the risk to patient safety in clinical settings.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
The recall could affect hospital workflows and patient safety until devices are remediated or replaced.
Practical Guidance
How to identify if yours is affected
- Step 1: Locate product label showing M8001A and UDI 00884838000193.
- Step 2: Verify serial numbers are included in recall (All serial numbers affected).
- Step 3: Stop use of affected devices and quarantine them from clinical use.
Where to find product info
Recall notices and device labeling will reference M8001A and UDI 00884838000193.
What timeline to expect
Hospitals should expect remediation guidance from Philips; replacement or service arrangements may take several weeks (typical range 4-8 weeks).
If the manufacturer is unresponsive
- Escalate to hospital recall administrator
- Contact FDA MedWatch if manufacturer is unresponsive
- Document all correspondence and remediation steps
How to prevent similar issues
- Verify device models and UDIs before purchase
- Maintain a device recall log at facilities
- Work with authorized service providers for replacements
- Monitor for additional recall notices and firmware updates
Documentation advice
Keep recall notices, device labels, UDI, and remediation communications in a dedicated file for compliance and records.
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Product Details
Product: IntelliVue MP20 Patient Monitor. Model/Item Number: M8001A. UDI-DI: 00884838000193. All Serial Numbers affected. Quantity: 1,913,441 units. Distribution: Worldwide, including US nationwide. Sold through hospital systems and medical distributors. Manufacturer: Philips North America LLC. Recall Date: 2025-10-31. Status: Active. Notable note: Notification by letter.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1.913 million units recalled
- M8001A product number
- All Serial Nos. affected
- Worldwide distribution including US
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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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