HIGH

Philips IntelliVue MP60 Recalled Over Alarm Malfunction Risk

Philips North America recalled 1,913,441 IntelliVue MP60 monitors on October 31, 2025. The monitors may fail to alarm, posing a significant risk to patient safety. Affected devices were distributed worldwide, including the United States and multiple countries.

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 IntelliVue MP60 has the product number M8005A and UDI-DI 00884838000186. The recall affects all serial numbers of the product. The monitors were sold worldwide.

The Hazard

The IntelliVue monitors may not alarm when needed, potentially leading to undetected medical emergencies. This hazard classifies the recall as Class II, indicating a moderate risk.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. The absence of alarms poses a serious risk, but no specific incident counts are available.

What to Do

Patients and healthcare providers should immediately stop using the IntelliVue MP60 monitors. 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-0855-2026. Philips North America's contact number is available on their official website.

Key Facts

  • 1,913,441 units recalled
  • Class II recall due to alarm malfunction
  • No reported injuries or deaths
  • Immediate stop-use instructions issued

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Safety Assessment

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

Product Classification

Product TypePatient Monitor
Sold At
Multiple Retailers

Product Details

Model Numbers
Product Number: M8005A
UDI-DI: 00884838000186
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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