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
- 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
- M8105A, UDI-DI 00884838000230
- Sold at
- Multiple Retailers
- 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 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.
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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
- Product: IntelliVue MP5 Monitor, M8105A
- Global distribution to hospitals and healthcare facilities
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Safety Guide
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