Philips IntelliVue Patient Monitors Recalled for Failure to Alarm

Agency Publication Date: December 2, 2025

Summary

Philips North America LLC is recalling approximately 1,913,441 units of various IntelliVue patient monitors and measurement modules due to a technical issue that may prevent the devices from sounding alarms. The affected products include a wide range of MP and MX series monitors as well as Multi-Measurement modules. Philips has initiated this voluntary recall after discovering that these monitors might not alert medical staff during patient events.

Risk

The failure of a patient monitor to sound an alarm during a critical change in a patient's health status can lead to delayed medical intervention. This poses a significant risk of serious injury or death, as healthcare providers rely on these alarms to respond to life-threatening conditions.

What You Should Do

This recall affects various Philips IntelliVue patient monitors including models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX100, MX400, MX450, MX500, MX550, MX600, MX700, MX750, MX800, and MX850, as well as Multi-Measurement modules X2 and X3.
Identify if your device is affected by checking the product number and UDI-DI on the device label. All serial numbers for the listed models are included in this recall. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device. Contact Philips North America LLC or your authorized distributor to arrange for a return, replacement, or corrective action as outlined in the notification letter sent by the firm.
Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

Other Action

Corrective action initiated by the firm.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: IntelliVue MP2 Patient Monitor

Model / REF:

M8102A

Serial Numbers:

All Serial Numbers

UDI:

00884838000278

Product Number: M8102A

Product: IntelliVue MP5 Patient Monitor

Model / REF:

M8105A

Serial Numbers:

All Serial Numbers

UDI:

00884838000230

Product Number: M8105A

Product: IntelliVue MP20 Patient Monitor

Model / REF:

M8001A

Serial Numbers:

All Serial Numbers

UDI:

00884838000193

Product Number: M8001A

Product: IntelliVue MP30 Patient Monitor

Model / REF:

M8002A

Serial Numbers:

All Serial Numbers

UDI:

00884838000155

Product Number: M8002A

Product: IntelliVue MP40 Patient Monitor

Model / REF:

M8003A

Serial Numbers:

All Serial Numbers

UDI:

00884838000162

Product Number: M8003A

Product: IntelliVue MP50 Patient Monitor

Model / REF:

M8004A

Serial Numbers:

All Serial Numbers

UDI:

00884838000179

Product Number: M8004A

Product: IntelliVue MP60 Patient Monitor

Model / REF:

M8005A

Serial Numbers:

All Serial Numbers

UDI:

00884838000186

Product Number: M8005A

Product: IntelliVue MP70 Patient Monitor

Model / REF:

M8007A

Serial Numbers:

All Serial Numbers

UDI:

00884838000209

Product Number: M8007A

Product: IntelliVue MP80 Patient Monitor

Model / REF:

M8008A

Serial Numbers:

All Serial Numbers

UDI:

00884838000216

Product Number: M8008A

Product: IntelliVue MP90 Patient Monitor

Model / REF:

M8010A

Serial Numbers:

All Serial Numbers

UDI:

00884838000223

Product Number: M8010A

Product: IntelliVue Multi Measurement Server X2

Model / REF:

M3002A

Serial Numbers:

All Serial Numbers

UDI:

00884838000261

Product Number: M3002A

Product: IntelliVue Multi-Measurement Module X3

Model / REF:

867030

Serial Numbers:

All Serial Numbers

UDI:

00884838082588

Product Number: 867030

Product: IntelliVue Patient Monitor MX100

Model / REF:

867033

Serial Numbers:

All Serial Numbers

UDI:

00884838082595

Product Number: 867033

Product: IntelliVue Patient Monitor MX400

Model / REF:

866060

Serial Numbers:

All Serial Numbers

UDI:

00884838038752

Product Number: 866060

Product: IntelliVue Patient Monitor MX450

Model / REF:

866062

Serial Numbers:

All Serial Numbers

UDI:

00884838038769

Product Number: 866062

Product: IntelliVue Patient Monitor MX500

Model / REF:

866064

Serial Numbers:

All Serial Numbers

UDI:

00884838038776

Product Number: 866064

Product: IntelliVue Patient Monitor MX550

Model / REF:

866066

Serial Numbers:

All Serial Numbers

UDI:

00884838038783

Product Number: 866066

Product: IntelliVue Patient Monitor MX600

Model / REF:

865242

Serial Numbers:

All Serial Numbers

UDI:

00884838029095

Product Number: 865242

Product: IntelliVue Patient Monitor MX700

Model / REF:

865241

Serial Numbers:

All Serial Numbers

UDI:

00884838029088

Product Number: 865241

Product: IntelliVue Patient Monitor MX750

Model / REF:

866471

Serial Numbers:

All Serial Numbers

UDI:

00884838083332

Product Number: 866471

Product: IntelliVue Patient Monitor MX800

Model / REF:

865240

Serial Numbers:

All Serial Numbers

UDI:

00884838020733

Product Number: 865240

Product: IntelliVue Patient Monitor MX850

Model / REF:

866470

Serial Numbers:

All Serial Numbers

UDI:

00884838070790

Product Number: 866470

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97917

Status: Active

Manufacturer: Philips North America Llc

Sold By: Authorized medical device distributors; Hospital supply chains; Philips direct sales

Manufactured In: United States

Units Affected: 22 products (1,913,441 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects various Philips IntelliVue patient monitors including models MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX100, MX400, MX450, MX500, MX550, MX600, MX700, MX750, MX800, and MX850, as well as Multi-Measurement modules X2 and X3.

Identify if your device is affected by checking the product number and UDI-DI on the device label. All serial numbers for the listed models are included in this recall. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device. Contact Philips North America LLC or your authorized distributor to arrange for a return, replacement, or corrective action as outlined in the notification letter sent by the firm.

Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Affected Products

Product: IntelliVue MP2 Patient Monitor

Model / REF:

M8102A

Serial Numbers:

All Serial Numbers

UDI:

00884838000278

Product Number: M8102A

Product: IntelliVue MP5 Patient Monitor

Model / REF:

M8105A

Serial Numbers:

All Serial Numbers

UDI:

00884838000230

Product Number: M8105A

Product: IntelliVue MP20 Patient Monitor

Model / REF:

M8001A

Serial Numbers:

All Serial Numbers

UDI:

00884838000193

Product Number: M8001A

Product: IntelliVue MP30 Patient Monitor

Model / REF:

M8002A

Serial Numbers:

All Serial Numbers

UDI:

00884838000155

Product Number: M8002A

Product: IntelliVue MP40 Patient Monitor

Model / REF:

M8003A

Serial Numbers:

All Serial Numbers

UDI:

00884838000162

Product Number: M8003A

Product: IntelliVue MP50 Patient Monitor

Model / REF:

M8004A

Serial Numbers:

All Serial Numbers

UDI:

00884838000179

Product Number: M8004A

Product: IntelliVue MP60 Patient Monitor

Model / REF:

M8005A

Serial Numbers:

All Serial Numbers

UDI:

00884838000186

Product Number: M8005A

Product: IntelliVue MP70 Patient Monitor

Model / REF:

M8007A

Serial Numbers:

All Serial Numbers

UDI:

00884838000209

Product Number: M8007A

Product: IntelliVue MP80 Patient Monitor

Model / REF:

M8008A

Serial Numbers:

All Serial Numbers

UDI:

00884838000216

Product Number: M8008A

Product: IntelliVue MP90 Patient Monitor

Model / REF:

M8010A

Serial Numbers:

All Serial Numbers

UDI:

00884838000223

Product Number: M8010A

Product: IntelliVue Multi Measurement Server X2

Model / REF:

M3002A

Serial Numbers:

All Serial Numbers

UDI:

00884838000261

Product Number: M3002A

Product: IntelliVue Multi-Measurement Module X3

Model / REF:

867030

Serial Numbers:

All Serial Numbers

UDI:

00884838082588

Product Number: 867030

Product: IntelliVue Patient Monitor MX100

Model / REF:

867033

Serial Numbers:

All Serial Numbers

UDI:

00884838082595

Product Number: 867033

Product: IntelliVue Patient Monitor MX400

Model / REF:

866060

Serial Numbers:

All Serial Numbers

UDI:

00884838038752

Product Number: 866060

Product: IntelliVue Patient Monitor MX450

Model / REF:

866062

Serial Numbers:

All Serial Numbers

UDI:

00884838038769

Product Number: 866062

Product: IntelliVue Patient Monitor MX500

Model / REF:

866064

Serial Numbers:

All Serial Numbers

UDI:

00884838038776

Product Number: 866064

Product: IntelliVue Patient Monitor MX550

Model / REF:

866066

Serial Numbers:

All Serial Numbers

UDI:

00884838038783

Product Number: 866066

Product: IntelliVue Patient Monitor MX600

Model / REF:

865242

Serial Numbers:

All Serial Numbers

UDI:

00884838029095

Product Number: 865242

Product: IntelliVue Patient Monitor MX700

Model / REF:

865241

Serial Numbers:

All Serial Numbers

UDI:

00884838029088

Product Number: 865241

Product: IntelliVue Patient Monitor MX750

Model / REF:

866471

Serial Numbers:

All Serial Numbers

UDI:

00884838083332

Product Number: 866471

Product: IntelliVue Patient Monitor MX800

Model / REF:

865240

Serial Numbers:

All Serial Numbers

UDI:

00884838020733

Product Number: 865240

Product: IntelliVue Patient Monitor MX850

Model / REF:

866470

Serial Numbers:

All Serial Numbers

UDI:

00884838070790

Product Number: 866470

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97917

Status: Active

Manufacturer: Philips North America Llc

Sold By: Authorized medical device distributors; Hospital supply chains; Philips direct sales

Manufactured In: United States

Units Affected: 22 products (1,913,441 units)

Distributed To: Nationwide