HIGH

PHILIPS IntelliVue MP80 Recall 1,913,441 Monitors Worldwide for Alarm Failure (2025)

Philips North America LLC recalled 1,913,441 IntelliVue MP80 patient monitors distributed worldwide to hospitals after reports the devices did not alarm. The defect could prevent alarms from sounding in critical patient situations. Healthcare facilities should stop using the monitors and follow recall instructions from the manufacturer.

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

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 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

  1. Identify devices by model M8008A and UDI 00884838000216
  2. Note that all serial numbers are affected as stated in the recall
  3. 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

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

  • 1,913,441 units recalled
  • Model M8008A
  • UDI-DI 00884838000216
  • Worldwide distribution to hospitals and healthcare providers
  • Status: ACTIVE as of 2025-12-10

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
9/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
M8008A
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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