HIGH

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.

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

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

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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.

The Hazard

The software patch alters Mobile Event Notification filter settings without user notification. This could lead to missed alerts and critical information gaps for patients and healthcare providers.

Reported Incidents

No injuries or incidents reported as a result of this software issue. The recall is classified as Class II, indicating a potential high hazard.

What to Do

Stop using the Patient Information Center software immediately. Follow the instructions provided by Philips North America and contact your healthcare provider.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1156-2026 or contact Philips North America directly.

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 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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