Is my Philips IntelliVue MP5 M8105A monitor recalled?

The recall applies to 1,913,441 MP5 monitors with product number M8105A. Verify your device's model number and UDI-DI 00884838000230 against the recall notice. If matched, stop using the device and follow the recall instructions.

What should I do if I own one of these monitors in a hospital setting?

Stop using the device immediately. Inform biomedical engineering and risk management. Contact Philips North America LLC for recall instructions and potential replacement or refund options.

How many monitors are affected by this recall?

1,913,441 units are affected worldwide, including US and other countries listed in the recall notice.

What is the hazard described in this recall?

The monitors may fail to alarm when a patient condition requires attention, potentially delaying clinical response.

Will there be a refund or replacement for affected monitors?

The recall notes a replacement-available and return-for-refund option. Follow the manufacturer’s recall instructions for next steps.

Where can I find the recall notice and contact information?

The recall is documented through the FDA enforcement report Z-0850-2026. Visit the FDA recall page linked in the notice for official instructions and contact details.

Are there any reported injuries from this recall?

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

What devices are covered by this recall?

IntelliVue MP5 monitors with Product Number M8105A, UDI-DI 00884838000230, and all serial numbers.

What is the recommended replacement strategy?

Hospitals may pursue a replacement monitor from Philips under the replacement-available option per recall instructions.

How long might refunds or replacements take?

Processing timelines are not specified in the notice. Typical recall timelines range from several weeks to a couple of months.

Should I continue using other Philips monitors?

Only devices explicitly recalled should be removed from service. Verify each device against recall details before use.

What documentation should I keep?

Retain the recall notice, correspondence with Philips, device serial numbers, and any replacement or refund receipts.

HIGHOctober 31, 2025

Philips IntelliVue MP5 M8105A Recall: 1,913,441 Monitors Worldwide Alarm Failure (2025)

Philips North America LLC is recalling 1,913,441 IntelliVue MP5 patient monitors sold to hospitals worldwide. The devices may fail to alarm, delaying detection of patient distress. Hospitals and clinicians should stop using the monitors immediately and follow Philips recall instructions.

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

The IntelliVue MP5 is a patient monitoring system used in clinical settings to track vital signs. It is deployed in hospitals to support continuous patient assessment and clinical decision making.

Why This Is Dangerous

If the monitor fails to alarm, clinical staff may not be alerted promptly to patient deterioration. This can delay life-saving interventions in critical care situations.

Industry Context

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

Real-World Impact

Hospitals must immediately implement the recall, stop using affected devices, and rely on alternative monitors or procedures to maintain patient safety while arrangements for replacement or refunds are completed.

Practical Guidance

How to identify if yours is affected

Verify device model M8105A and UDI-DI 00884838000230 on the unit label.
Confirm the device is listed in the recall notice and associated with Philips IntelliVue MP5 monitors.
Check the serial number status and any recall-specific documentation or letters from Philips.

Where to find product info

Find model numbers and UDI on the device label, packaging, and in the recall notice. Detailed instructions are on the FDA enforcement page linked in the notice.

What timeline to expect

Refund or replacement processing may take several weeks. Hospitals should coordinate with Philips for interim safety protocols.

If the manufacturer is unresponsive

Escalate to hospital risk management and biomedical engineering.
File a formal inquiry with Philips support if there is no timely response.
Consult FDA guidance if the manufacturer is unresponsive.

How to prevent similar issues

Establish a routine check of recall notices for critical devices in use.
Verify UDIs during device procurement to avoid unlisted models.
Require documented recall response plans for medical devices.

Documentation advice

Keep the recall letter, incident logs, and replacement or refund correspondence. Photograph labels and serial numbers for records.

Product Details

Model numbers: M8105A. UDI-DI: 00884838000230. All Serial No. Distribution: Worldwide. Sold to hospitals and healthcare facilities. Sold from unknown date. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

1,913,441 units affected
Product: IntelliVue MP5 Monitor, M8105A
UDI-DI: 00884838000230
Global distribution to hospitals and healthcare facilities

View Original Recall on FDA - Medical Devices

Browse More Recalls

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypePatient Monitor

Product Details

May 9, 2026

BMW

A damaged