What product is recalled?

The Philips IntelliVue MX600 patient monitor with Product Number 865242 is recalled. A total of 1,913,441 units worldwide are affected.

Why is this recall issued?

The recall concerns a potential issue where the monitors did not alarm, which could delay recognition of patient distress.

Are there any injuries tied to this recall?

No injuries or incidents have been reported in the recall notice.

What should I do if I own one of these monitors?

Stop using the device immediately. Follow the recall instructions from Philips and contact your healthcare provider or Philips North America LLC for guidance.

How can I identify if my monitor is affected?

Check the Product Number 865242 and the UDI-DI 00884838029095. All serial numbers are affected.

Where were these monitors distributed?

There was worldwide distribution, including US nationwide and many other countries.

Will I get a replacement or refund?

The remedy described is to stop using the device and follow Philips’ recall instructions. Refunds or replacements will be provided per Philips’ recall process.

How long will the process take?

The recall notice does not specify timelines for refunds or replacements.

Where can I find more information?

The recall is listed on the FDA enforcement page for Z-0866-2026. The notice provides 865242 and 00884838029095 details.

Who is issuing the recall?

Philips North America LLC is issuing the recall in coordination with global distribution.

Is this recall regulated by a federal agency?

Yes, it falls under U.S. regulatory oversight for medical devices and is subject to FDA recall processes.

What if my hospital isSlow to respond?

Consult your hospital risk management team and contact Philips Customer Care for escalation. You may also report concerns to the FDA if needed.

What should I do to prevent similar issues in the future?

Regularly check for recalls on hospital devices, verify model numbers and UDIs, and ensure devices are serviced through authorized channels.

Can I use a similar Philips monitor during the recall?

Only after confirming it is not affected by this recall and following manufacturer guidance.

HIGHOctober 31, 2025

Philips IntelliVue MX600 Patient Monitor Recall 2025 for Alarm Failure

Philips recalled 1,913,441 IntelliVue MX600 patient monitors distributed worldwide after reports that the devices did not alarm. The defect could prevent alarms that alert clinicians to patient distress. Hospitals and clinicians should stop using the devices immediately and follow the recall instructions from Philips North America LLC.

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

IntelliVue MX600 is a patient monitoring system used in clinical settings to track vital signs. It is designed to alert clinicians to deteriorating patient conditions.

Why This Is Dangerous

The defect can cause monitors to fail to emit alarms when a patient’s condition requires attention, potentially delaying intervention.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and clinicians must stop using these devices and await replacement or repair instructions to ensure patient safety.

Practical Guidance

How to identify if yours is affected

Check Product Number 865242 on the device label.
Check UDI-DI 00884838029095 on the label.
Confirm the device is a MX600 model and was distributed by Philips.

Where to find product info

On device labels, packaging, and hospital asset records; recall communications from Philips.

What timeline to expect

Remedies are handled by Philips through replacement or repair channels; specific timelines are not provided in the notice.

If the manufacturer is unresponsive

Escalate with the hospital risk management team.
Contact Philips Customer Care for escalation.
If needed, file a complaint with the FDA.

How to prevent similar issues

Check recalls before deploying hospital devices.
Verify model numbers and UDIs with the manufacturer.
Maintain an up-to-date inventory of monitored devices and their recall status.

Documentation advice

Keep copies of the recall notice, all correspondence with Philips, and records of the affected device identifiers.

Product Details

Model numbers: Product Number 865242; UDI-DI: 00884838029095; All Serial Nos. affected; Distribution: Worldwide including US nationwide and many countries; Sold quantities or price: Not disclosed.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

1,913,441 units recalled
Product Number 865242
UDI-DI 00884838029095
All Serial Nos affected
Worldwide distribution including US
Recall date 2025-10-31

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

ELECTRICALOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypePatient Monitor (IntelliVue MX600)

Product Details

May 9, 2026

BMW

A damaged