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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 Llc: Patient Information Center iX Recalled for Software Crash and Blank Screen

Agency Publication Date: September 19, 2023
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Summary

Approximately 960 units of the Philips Patient Information Center (PIC iX) Release 4.x are being recalled due to a software error involving Intel Graphics Drivers. This defect causes the monitoring surveillance system to crash and the screen to go blank, which stops the active monitoring of patients. When this occurs, healthcare staff must manually reboot the hardware to restore the system and continue patient monitoring. This recall affects models including PIC iX, PIC iX Expand, and PIC iX Essentials.

Risk

A system crash leads to a blank monitoring screen, which creates a critical gap in patient surveillance. This failure can result in a delay in detecting life-threatening changes or the deterioration of a patient's condition because the central station is unable to display or alert staff to vital sign changes while the system is down.

What You Should Do

  1. Identify if your facility is using Patient Information Center iX (866389), PIC iX Expand (866390), PIC iX Essentials (867093), or PIC iX Essentials Expand (867154) with Software Version 4.x.
  2. Check your system identifiers for the following UDI codes: (01)00884838104594(10)4.0.1, (01)00884838104594(10)4.0.2, or (01)00884838112070(10)4.1.0.
  3. If the surveillance system crashes and the screen goes blank, perform a manual reboot of the hardware immediately to restart the system and resume patient monitoring.
  4. Contact Philips North America Llc or your local technical representative for further instructions on how to resolve the graphics driver error.
  5. Report any incidents of system failure or patient harm related to this issue to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
  6. 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

Manual hardware reboot and manufacturer contact

How to: Perform a manual reboot of the hardware to restart and continue monitoring. Contact your healthcare provider or the manufacturer for further instructions and potential technical updates.

Affected Products

Product: Patient Information Center iX
Model / REF:
866389
UDI (01)00884838104594(10)4.0.1
UDI (01)00884838104594(10)4.0.2
Lot Numbers:
Software Version 4.x
Product: Patient Information Center iX Expand
Model / REF:
866390
UDI (01)00884838104594(10)4.0.1
UDI (01)00884838104594(10)4.0.2
Lot Numbers:
Software Version 4.x
Product: PIC iX Essentials
Model / REF:
867093
UDI (01)00884838112070(10)4.1.0
Lot Numbers:
Software Version 4.x
Product: PIC iX Essentials Expand
Model / REF:
867154
UDI (01)00884838112070(10)4.1.0
Lot Numbers:
Software Version 4.x

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92992
Status: Active
Manufacturer: Philips North America Llc
Sold By: Philips direct sales; Authorized medical device distributors
Manufactured In: United States
Units Affected: 960 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.

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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.