HIGH

Philips IntelliVue MX850 Patient Monitor Recall for Alarm Failure Affects 1,913,441 Units (2025)

Philips recalled 1,913,441 IntelliVue MX850 patient monitors worldwide after reports the devices may fail to alarm. The issue could prevent critical alarms from sounding. Hospitals and patients should stop using the device immediately and follow recall instructions sent by Philips via letter.

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 MX850 is a patient monitor used in hospital settings to track vital signs and clinical data. It is designed for continuous observation of patients in acute care environments.

Why This Is Dangerous

If the device fails to alarm, clinicians may miss signs of patient deterioration, delaying critical interventions.

Industry Context

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

Real-World Impact

Hospitals may need to halt use of affected units, replace equipment, and re-train staff to ensure monitoring continuity. Consumers could face treatment delays if devices are not returned promptly.

Practical Guidance

How to identify if yours is affected

  1. Check device Product Number: 866470
  2. Check UDI-DI: 00884838070790
  3. Note that all serial numbers are affected

Where to find product info

Serial numbers and product identifiers are on the device label, packaging, and recall communications

What timeline to expect

4-8 weeks for refunds or replacements after approval

If the manufacturer is unresponsive

  • File a formal complaint with the hospital risk management team
  • Contact Philips North America LLC for escalation
  • Consult FDA recall resources if the manufacturer is unresponsive
  • Document all communications and retain copies

How to prevent similar issues

  • Verify device recall status before shipment to care areas
  • Maintain an up-to-date asset registry with model numbers and UDI codes
  • Establish clear recall response procedures for medical devices
  • Ask vendors for recall notification procedures during procurement

Documentation advice

Keep the recall letter, take photos of the device label, maintain a log of all communications and dates, store correspondence with Philips and the hospital.

Product Details

Model numbers: Product Number 866470; UDI-DI 00884838070790. Sold worldwide; US nationwide and many countries listed in recall. Recall date: 2025-10-31. Quantity: 1,913,441 units. Price: Unknown. Serial numbers: All Serial No.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1,913,441 units recalled
  • Product Number 866470
  • UDI-DI 00884838070790
  • All Serial Numbers affected
  • Worldwide distribution including US
  • Recall date 2025-10-31

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

Product TypePatient Monitor
Sold At
Multiple Retailers

Product Details

Brand
Model Numbers
Product Number: 866470
UDI-DI: 00884838070790
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Philips Allura Xper FD20/15 OR Table Recall for 8 Units Worldwide in 2026

Philips Medical Systems Nederland B.V. recalls 8 Allura Xper FD20/15 OR Tables worldwide due to a risk that X-ray imaging may not start or may stop intermittently when using the wired foot switch. The issue is tied to System Code 722059 and requires immediate action. Hospitals and patients should stop using the device and follow the manufacturer’s recall instructions.

Philips
Philips has
Read more
Health & Personal Care
HIGH

Philips Azurion 7 M12 Recall 2026 for Intermittent X-ray Imaging in 1994 Units

Philips recalled 1,994 Azurion 7 M12 interventional X-ray systems, including 360 units in the United States, for a wiring-foot switch defect that may fail to initiate imaging. The issue can cause imaging to not start or operate intermittently. Hospitals and clinicians should stop using affected devices immediately and follow the manufacturer’s recall instructions.

Philips
Philips has
Read more
Health & Personal Care
HIGH

Philips Allura Xper FD20 Biplane Recalled for Intermittent X-Ray Imaging (2026)

Philips Medical Systems Nederland B.V. recalled 461 Allura Xper FD20 Biplanes sold to healthcare facilities nationwide and internationally. X-ray imaging may not initiate or may occur intermittently when using the wired foot switch. Hospitals should stop using the devices immediately and follow Philips’ recall instructions.

Philips
Philips has
Read more
Health & Personal Care
HIGH

Philips Azurion 7 B20 Interventional X-ray System Recall for 1,523 Units (2026)

Philips Medical Systems Nederland B.V. recalls 1,523 Azurion 7 B20 interventional X-ray systems used by hospitals nationwide after possible failure to initiate X-ray imaging. The defect affects whether imaging starts when using the wired foot switch. Hospitals should stop using the device and follow Philips recall instructions immediately.

Philips
Philips has
Read more
Health & Personal Care
HIGH

Philips Tempus Pro Patient Monitor Recalled Over Accuracy Issues

Philips recalled 7,129 Tempus Pro Patient Monitors on November 26, 2025. The monitors may provide unvalidated measurements for Intracranial Pressure and Bladder Pressure. Incorrect readings could lead to critical clinical decisions.

Philips
Patient monitor
Read more