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