Quick Facts at a Glance
- Recall Date
- December 22, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- 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 North America
- Product type
- Patient Information Center Software
- Model numbers
- Model Numbers: (1) 866389, (2) 866390, UDI-DI: (1) 00884838127074, (2) N/A, Serial Numbers: 4Z24-5CKL-P, 0P6C-4TL3-D, 6J58-3LL6-0, 216G-7PGV-E +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 22, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
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 or your healthcare provider for instructions. Notification method: Letter
About This Product
The Patient Information Center software is designed to facilitate communication and notifications for healthcare providers and patients. Users typically rely on it for timely health alerts and event notifications.
Why This Is Dangerous
The recent software patch modifies notification settings without informing users, potentially leading to missed alerts critical for patient care. This change can compromise effective communication in healthcare settings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience for users who depend on this software for notifications, but it poses a serious risk due to the potential for missed alerts.
Practical Guidance
How to identify if yours is affected
- Check the software version to confirm if it is 4.5.0
- Verify model numbers against the recalled list: 866389, 866390
- Look for serial numbers on your device to confirm if it is affected.
Where to find product info
Serial numbers can usually be found in the software settings or on the original packaging.
What timeline to expect
Expect a response from Philips North America within 4-6 weeks for further instructions or updates.
If the manufacturer is unresponsive
- Contact Philips customer service directly.
- Reach out to your healthcare provider for assistance.
How to prevent similar issues
- Always verify software version compatibility before updates.
- Check for notification settings after software updates.
- Consult with healthcare providers on software reliability.
Documentation advice
Keep records of all correspondence with Philips, including emails and letters regarding the recall.
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Product Details
Recalled software version: 4.5.0. Model numbers include 866389 and 866390. Serial numbers include 4Z24-5CKL-P and 0P6C-4TL3-D.
Key Facts
- Recalled software version: 4.5.0
- Total units recalled: 146
- 41 units sold in the U.S.
- Immediate action required
- Contact Philips for instructions
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Safety Guide
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