Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Monitoring Devices

Philips North America: Patient Monitoring Software Recalled for Silenced Notification Alarms

Agency Publication Date: March 27, 2024
Share:
Sign in to monitor this recall

Summary

Philips North America is recalling several patient monitoring software systems, including the Patient Information Center iX (PIC iX) and the CareEvent Event Management System, affecting a total of 259,506 units worldwide. The recall was initiated because the Care Assist mobile application (version 4.1.1 and earlier) may fail to play custom ringtones for patient alerts when an iOS device screen is locked with a passcode. This failure could prevent healthcare providers from receiving critical patient notifications in a timely manner. If you use these systems, please contact your healthcare provider or Philips for further instructions regarding software updates.

Risk

If the Care Assist application fails to play custom ringtones while the phone is locked, healthcare staff may miss urgent patient alarms or clinical events. This delay in notification could lead to a lack of immediate medical intervention for patients in critical condition, potentially resulting in serious injury or death.

What You Should Do

  1. Identify if your facility uses Patient Information Center iX (PIC iX) models 866389, 866390, or 866424 running software version 4.X.
  2. Identify if your facility uses the CareEvent Event Management System models 866435 or 866436 running software version C.03.X.
  3. Check the version of your Care Assist mobile application; version 4.1.1 and earlier are specifically affected by this ringtone issue.
  4. Verify your device serial numbers against the extensive list provided in the recall notice, including UDI-DI (01)00884838104594(10)4.0.1 through (01)00884838121782(10)4.2.1 for PIC iX, and (01)00884838099128(10)C.03.00 for CareEvent.
  5. Contact Philips North America or your clinical IT department to ensure the software is updated or that mitigation steps are in place to ensure alerts are heard while devices are locked.
  6. Contact Philips North America directly at their Cambridge, Massachusetts office or through their official website for technical support and remedy instructions.
  7. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software update or technical mitigation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Patient Information Center iX (PIC iX)
Model / REF:
866389
866390 (PIC iX Expand)
866424 (PIC iX Hardware)
UPC Codes:
00884838104594
00884838112070
00884838121782
Lot Numbers:
7G6G-7PGV-W
5971-2NL7-Z
6D62-19MD-9
463N-67ME-X
5K2A-6DHP-K
5E42-35J4-P
4E6Z-70HU-B
1T12-0MNA-C
2H34-3MMP-U
6P1E-7HJU-W
Product: CareEvent Event Management System
Model / REF:
866435
866436 (CareEvent Upgrade)
UPC Codes:
00884838099128
Lot Numbers:
5T6W-21KC-4
3L0R-7AHH-C
1F1G-01JC-6
415A-26K6-9
605K-5AGH-2
5J5G-0ZNF-4
7A6D-4TL3-Y
233Z-0LJ3-C

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94185
Status: Active
Manufacturer: Philips North America
Sold By: Philips North America; Direct medical distribution
Manufactured In: United States
Units Affected: 2 products (257,183 Units; 2,323 Units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.