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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 and Veradius Medical Systems Recalled for Radiation Risk

Agency Publication Date: April 21, 2025
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Summary

Philips North America is recalling several models of mobile X-ray systems, including the Zenition 50, Zenition 70, and Veradius Unity. These medical devices are used to provide imaging guidance for doctors during surgeries and diagnostic procedures. The recall is being issued because the wireless foot switch pedal can become stuck in the active position even after the operator stops pressing it, causing the machine to continue emitting radiation. No injuries have been reported in connection with this defect.

Risk

A stuck foot switch causes the X-ray system to emit unintended radiation. This defect poses a risk of unnecessary radiation exposure to both patients and medical staff, which could lead to radiation-related health complications over time.

What You Should Do

  1. This recall involves Zenition 50, Zenition 70, and Veradius Unity mobile C-arm X-ray systems equipped with specific wireless foot switch components.
  2. Identify your device by checking the product label for model names Zenition 50 (Product Code 718096), Zenition 70 (Product Code 718133), or Veradius Unity (Product Code 718132).
  3. The affected systems use wireless foot switch components with part numbers 459801442981, 459801238231, 459801257861, 459800627394, 459800415535, and 459800415542. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled device immediately. Contact Philips North America or your authorized medical device distributor to arrange for a return, replacement, or correction of the wireless foot switch system.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

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 Mobile C-arm X-ray System
Model / REF:
718096
459801442981
459801238231
459801257861
459800627394
459800415535
459800415542
UDI:
00884838091535

Includes Wireless foot switch set 3P (WFSS 3P), Wireless foot switch 3P, and WFS Base Station.

Product: Zenition 70 Mobile C-arm X-ray System
Model / REF:
718133
459801442981
459801238231
459801257861
459800627394
459800415535
459800415542
UDI:
00884838091528

Includes Wireless foot switch set 3P (WFSS 3P), Wireless foot switch 3P, and WFS Base Station.

Product: Veradius Unity Mobile C-arm X-ray System
Model / REF:
718132
459801442981
459801238231
459801257861
459800627394
459800415535
459800415542
UDI:
00884838058194

Includes Wireless foot switch set 3P (WFSS 3P), Wireless foot switch 3P, and WFS Base Station.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96593
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized Medical Device Distributors
Manufactured In: United States
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.