HIGH

Philips IntelliVue MP20 Recall Expands to 1.9 Million Units Over Alarm Failure Risk (2025)

Philips recalls 1.913 million IntelliVue MP20 patient monitors worldwide because the devices may fail to alarm. The issue could prevent critical alerts from sounding. Hospitals should stop using the monitors immediately and follow Philips recall instructions.

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

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

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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

  1. Step 1: Locate product label showing M8001A and UDI 00884838000193.
  2. Step 2: Verify serial numbers are included in recall (All serial numbers affected).
  3. 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.

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
  • UDI-DI 00884838000193
  • All Serial Nos. affected
  • Worldwide distribution including US
  • Recall Date 2025-10-31

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
Product Number: M8001A
UDI-DI: 00884838000193
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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