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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.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
October 31, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Philips
Product type
Patient Monitor (IntelliVue MX600)
Model numbers
865242, UDI-DI 00884838029095
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 31, 2025

  2. Reported by FDA DEVICE

    December 10, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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

  1. Check Product Number 865242 on the device label.
  2. Check UDI-DI 00884838029095 on the label.
  3. 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.

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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

  • All Serial Nos affected
  • Worldwide distribution including US

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Details

Brand
Model Numbers
865242
UDI-DI 00884838029095
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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