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Philips North America Issues Recall for Patient Information Center Software

Philips North America recalled 146 units of Patient Information Center software on December 22, 2025. A software patch modifies Mobile Event Notification filter settings without notifying users. The recall affects units distributed worldwide, including 41 in the U.S.

Official notice
Philips North AmericaHealth & Personal CareMedical DevicesModel Numbers: (1) 866389(2) 866390UDI-DI: (1) 00884838127074

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 22, 2025
Status
ACTIVE
Severity
8/10

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    December 22, 2025

  2. Reported by FDA DEVICE

    January 28, 2026

  3. RecallRadar source check

    February 4, 2026

  4. 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

  1. Check the software version to confirm if it is 4.5.0
  2. Verify model numbers against the recalled list: 866389, 866390
  3. 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

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

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Model Numbers: (1) 866389
(2) 866390
UDI-DI: (1) 00884838127074
(2) N/A
Serial Numbers: 4Z24-5CKL-P
+15 more
Affected States
ALL
Report Date
January 28, 2026
Recall Status
ACTIVE

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