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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.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Philips North America: Patient Information Center iX and CareEvent Recalled for Notification Failure

Agency Publication Date: January 13, 2024
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Summary

Philips North America is recalling several patient monitoring systems, including the Patient Information Center iX (PIC iX) and CareEvent software, because push notifications may fail to send under certain conditions. Approximately 295 units in the U.S. and 810 units internationally are affected by this software defect. The recall includes PIC iX Version 4.X and CareEvent Version C.03.X, which were distributed to hospitals and healthcare facilities across various U.S. states and dozens of countries. Because these notifications are used to alert staff to changes in a patient's status, consumers and healthcare providers should contact the manufacturer for technical instructions on how to mitigate this risk.

Risk

The failure of push notifications can cause a delay in detecting critical changes in a patient's condition. This delay in medical response could lead to patient harm if clinical staff are not alerted to life-threatening events in a timely manner.

What You Should Do

  1. Identify if your facility is using the affected Patient Information Center iX (PIC iX) Version 4.X or CareEvent Version C.03.X software by checking the system settings or hardware labels.
  2. For Patient Information Center iX, check for model numbers 866389, 866390, or 866424 with UDI-DI codes 00884838104594, 00884838112070, or 00884838121782.
  3. For CareEvent systems, check for model numbers 866435 or 866436 with UDI-DI code 00884838099128.
  4. Contact Philips North America or your healthcare provider immediately to receive specific guidance and potential software updates or patches required to fix the notification issue.
  5. Do not rely solely on mobile push notifications for critical patient monitoring until the manufacturer has confirmed your system is functioning correctly.
  6. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer technical notification and guidance

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

Affected Products

Product: Patient Information Center iX
Model / REF:
866389
Lot Numbers:
Software: PIC iX Version 4.X
Product: Patient Information Center iX Expand
Model / REF:
866390
Lot Numbers:
Software: PIC iX Version 4.X
Product: PIC iX Hardware
Model / REF:
866424
Lot Numbers:
Software: PIC iX Version 4.X
Product: CareEvent
Model / REF:
866435
Lot Numbers:
Software: CareEvent Version C.03.X
Product: CareEvent Upgrade
Model / REF:
866436
Lot Numbers:
Software: CareEvent Version C.03.X

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93638
Status: Active
Manufacturer: Philips North America
Sold By: Philips North America
Manufactured In: United States
Units Affected: 2 products (41 US; 773 OUS; 254 US; 37 OUS)
Distributed To: California, Georgia, Iowa, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, West Virginia

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.