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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/Diagnostic Equipment

Philips Zenition 50 X-Ray Systems Recalled for Image Quality Issues

Agency Publication Date: October 23, 2025
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Summary

Philips Medical Systems Nederland B.V. is recalling 29 Zenition 50 interventional fluoroscopic x-ray systems. These systems may experience a total loss of imaging functionality or poor image quality because an internal control board can corrode over time. If the system fails during a medical procedure, doctors may be unable to see the live x-ray images needed to guide their work, potentially leading to treatment delays.

Risk

Corrosion on the Image Intensifier Television (IITV) control board can cause x-ray images to become blurry or disappear entirely. This defect could lead to delayed procedures or the need for additional medical interventions if the equipment fails while a patient is undergoing a procedure.

What You Should Do

  1. This recall affects Philips Zenition 50 interventional fluoroscopic x-ray systems with product number (REF) 718096 and UDI-DI 00884838091535.
  2. Identify your device by checking the product number and serial number printed on the device identification label. This recall applies to all serial numbers for the specified model.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. If you have additional questions, call the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Zenition 50 Interventional fluoroscopic x-ray system
Model / REF:
718096
Serial Numbers:
All serial numbers
UDI:
00884838091535

Recall number Z-0241-2026. Affected quantity: 29 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97682
Status: Active
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sold By: authorized medical equipment distributors
Manufactured In: Netherlands
Units Affected: 29 units
Distributed To: Missouri, Texas

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.