HIGH

Philips IntelliVue MP5 Monitors Recalled Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP5 monitors on October 31, 2025, due to a failure to alarm. The recall affects devices distributed worldwide, including the United States. Patients and healthcare providers must stop using the monitors immediately.

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 MP5, Product Number: M8105A. It has a UDI-DI of 00884838000230 and includes all serial numbers. The devices were distributed worldwide.

The Hazard

The IntelliVue MP5 monitors may fail to alarm, posing a significant risk to patient safety. The U.S. Food and Drug Administration classified this recall as Class II, indicating a potential for temporary or medically reversible adverse health consequences.

Reported Incidents

No specific reported incidents or injuries have been mentioned in the recall notice. The high hazard level suggests that the potential for serious consequences is significant.

What to Do

Stop using the IntelliVue MP5 monitors immediately. Follow the manufacturer's instructions for returning the device. Contact Philips North America or your healthcare provider for further instructions.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0850-2026 or call Philips North America.

Key Facts

  • Recall date: October 31, 2025
  • Quantity recalled: 1,913,441 units
  • Affected countries include the U.S. and worldwide
  • Class II recall due to alarm failure

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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: M8105A
UDI-DI: 00884838000230
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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