HIGH

Philips IntelliVue MP40 Monitors Recalled Over Alarm Failure

Philips recalled 1,913,441 IntelliVue MP40 monitors on October 31, 2025, due to a failure to alarm. This defect poses a high risk to patient safety. The recall affects devices distributed worldwide, including in the US.

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brand
Philips North America
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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Product Details

The recalled product is the IntelliVue MP40, Product Number: M8003A, with UDI-DI: 00884838000162. The monitors were distributed globally and sold through multiple healthcare channels.

The Hazard

The IntelliVue MP40 monitors may fail to alarm, preventing timely alerts for patient conditions. This malfunction can lead to critical patient safety risks.

Reported Incidents

There are no specific reported incidents or injuries associated with this recall. However, the alarm failure presents a high risk to patient care.

What to Do

Stop using the IntelliVue MP40 monitors immediately. Patients and healthcare providers should follow the recall instructions provided by Philips North America and contact their healthcare provider for guidance.

Contact Information

For further information, contact Philips North America LLC. Visit https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0853-2026 for details.

Key Facts

  • 1,913,441 units recalled
  • Failure to alarm poses high risk
  • Global distribution including the US
  • Immediate action required to stop use

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Product Number: M8003A
UDI-DI: 00884838000162
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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