HIGH

Philips IntelliVue MP50 Monitors Recalled Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP50 monitors on October 31, 2025. The monitors may fail to alarm, posing a high risk to patient safety. Healthcare providers must stop using the devices immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brand
Philips North America
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

Product Details

The recalled product is the IntelliVue MP50, Product Number: M8004A. It was distributed worldwide, including the United States and over 100 countries. The monitors were sold for an unspecified price.

The Hazard

The IntelliVue MP50 monitors may not alarm during critical situations, potentially endangering patients. This defect could lead to delayed responses to medical emergencies.

Reported Incidents

There are no specific incident numbers or injury reports mentioned in the recall data. The nature of the hazard presents a high potential risk to patients.

What to Do

Patients and healthcare providers should stop using the IntelliVue MP50 monitors immediately. Contact Philips North America LLC or your healthcare provider for instructions on the recall process.

Contact Information

For more information, contact Philips North America at 1-800-xxx-xxxx or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0854-2026.

Key Facts

  • Recalled product: IntelliVue MP50, Product Number: M8004A
  • Total units recalled: 1,913,441
  • Recall issued on October 31, 2025
  • High hazard level due to alarm failure
  • Worldwide distribution, including the US

Get Alerts for Health & Personal Care Recalls

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

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Product Number: M8004A
UDI-DI: 00884838000179
All Serial No.
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
Read more