Quick Facts at a Glance
- Recall Date
- October 31, 2025
- Hazard Level
- HIGH
- Brand
- Philips
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- Model numbers
- M8005A, UDI-DI: 00884838000186
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 31, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
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
The IntelliVue MP60 is a patient monitor used in hospital settings to track vital signs and alarms. It is part of Philips' IntelliVue line of medical devices.
Why This Is Dangerous
If the monitor fails to alarm as designed, clinicians may miss critical patient events, delaying urgent responses.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided notice.
Real-World Impact
Hospitals must identify affected units and quarantine them to prevent use while awaiting replacement or repair guidance. The recall involves a large global distribution and has potential patient-safety implications.
Practical Guidance
How to identify if yours is affected
- Confirm device model is M8005A (IntelliVue MP60).
- Verify UDI-DI is 00884838000186 on the device label.
- Check that the device has any serial number listed as 'All Serial No.'
- Compare against the recall notice to ensure it is within the worldwide distribution.
Where to find product info
Identifiers can be found on the label on the device and in the recall notice.
What timeline to expect
Refund or replacement timelines are not specified in the notice.
If the manufacturer is unresponsive
- Escalate to hospital procurement or biomedical engineering.
- Contact Philips through official recall channels for assistance.
How to prevent similar issues
- Screen all MP60 devices in inventory for the M8005A model and 00884838000186.
- Establish a recall-handling protocol with biomedical engineering.
Documentation advice
Document device model, UDI, serial numbers, date of recall notice, and all communications with Philips.
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Product Details
Product: IntelliVue MP60, Product Number M8005A. Quantity: 1,913,441 units. UDI-DI: 00884838000186. All Serial No. Distribution: Worldwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: M8005A; UDI-DI: 00884838000186; All Serial No.
- Distribution: Worldwide, including US nationwide
- Hazard: Monitor may fail to alarm when monitoring patients
- Remedy: Stop using the device and follow recall instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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