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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 Patient Information Center iX Software Recalled for Sync Failure

Agency Publication Date: October 8, 2024
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Summary

Philips North America has recalled approximately 591 units of its Patient Information Center iX and Patient Information Center iX Expand software (Software Revision 4.0.1). During extended use, the software can lose connection with patient monitoring devices, resulting in a failure to synchronize important monitoring settings and alarms. No injuries or incidents have been reported to date in connection with this software defect.

Risk

If the software fails to sync settings, clinicians may not receive critical patient data or updated alarm configurations. This could lead to a delay in recognizing changes in a patient's condition, potentially resulting in serious injury or delayed medical intervention.

What You Should Do

  1. This recall affects the Patient Information Center iX (Product Code 866386) and Patient Information Center iX Expand (Product Code 866390) running Software Revision 4.0.1.
  2. Clinicians should check their system information to determine if the software revision is 4.0.1 and verify the device serial number. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled software version and contact Philips North America or your healthcare distributor to arrange for a software update, correction, or replacement.
  4. For additional questions or to report clinical issues, call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled software version. Contact Philips North America or your healthcare distributor to arrange for a software update, correction, or replacement.

Affected Products

Product: Patient Information Center iX and Patient Information Center iX Expand
Variants: Software Revision 4.0.1
Model / REF:
866386
866390
Serial Numbers (591):
0Y5Z-7FHX-N
5H20-1DNN-E
1762-74NU-5
1C0V-08NR-0
6U53-30PD-1
6M5J-0JLM-H
2M2G-15LB-E
4U3A-3JGK-K
0439-16GM-G
3A1T-22HW-U
534U-57JE-Y
0D6U-5ZH1-D
3H5C-6JK9-X
3K0C-3EH3-H
3Z47-12JD-V
524N-43JR-2
5N40-2RHR-N
1331-5BNT-B
1V4F-34MB-G
1B4R-37N1-3
6D3L-28MC-M
7Y52-29H4-L
7Y5Z-7FHX-F
1X6W-21KC-W
6278-09GU-Y
2C6N-3KLU-C
3E5Y-32PN-4
5T2L-2TP9-V
021Z-1WJ2-5
1W6W-21KC-Z
7L3H-46MR-L
194D-2YHB-T
1Y7A-49M4-6
2Z3C-1AHM-3
4T51-53NK-A
1P4A-44NB-V
3B5M-55J9-5
5V57-0HN3-J
7V5Z-7FHX-R
224B-2HJF-F
5G1G-01JC-Z
6Y7F-06MT-0
676T-6XMZ-M
5F1G-01JC-2
5K2B-6DHP-4
5T45-7ELE-C
0V7B-4EJH-A
1F23-36KM-0
2C50-6KKD-R
3107-4RG3-6
UDI:
00884838104594

Recall #: Z-0035-2025. This recall specifically targets Software Revision 4.0.1.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95325
Status: Active
Manufacturer: Philips North America
Sold By: Philips North America; Healthcare distributors
Manufactured In: United States
Units Affected: 591 devices
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.