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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 70 Imaging Systems Recalled for Unintended Radiation Risk

Agency Publication Date: April 21, 2025
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Summary

Philips Medical Systems Nederland B.V. has recalled 12 Zenition 70 Imaging Systems equipped with the Vascular Extension option and a Wireless Foot Switch. The recall was issued because these systems may deliver unintended radiation exposure to patients and medical staff during procedures. No incidents or injuries have been reported to date. Healthcare facilities should contact the manufacturer or their authorized distributor to arrange for a correction or return of the equipment.

Risk

The combination of the Vascular Extension and Wireless Foot Switch may cause the imaging system to emit radiation when not intended. This poses a risk of unnecessary radiation exposure to both patients and healthcare providers in the vicinity of the device.

What You Should Do

  1. This recall involves Zenition 70 Imaging Systems that are configured with both the Vascular Extension option and a Wireless Foot Switch.
  2. Check the identification label on your imaging system to confirm it is a Zenition 70 model and verify if your unit is equipped with the Vascular Extension and Wireless Foot Switch options.
  3. Stop using the recalled device immediately.
  4. Contact Philips Medical Systems Nederland B.V. or your authorized medical equipment distributor to arrange for a return, replacement, or correction of the system.
  5. Call the FDA at 1-888-463-6332 for more information or to report any adverse events related to this device.

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 70 Imaging System
Variants: Vascular Extension option, Wireless Foot Switch
Model / REF:
Zenition 70

The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96598
Status: Active
Manufacturer: Philips Medical Systems Nederland B.V.
Sold By: authorized medical equipment distributors
Manufactured In: Netherlands
Units Affected: 12 systems
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.