GE OEC Medical Systems, Inc. has recalled approximately 287 OEC 3D, OEC Elite, OEC 9900, and OEC 9800 mobile fluoroscopic X-ray systems due to a manufacturing defect. The X-ray tubes in these systems may have been insufficiently sealed, which can lead to oil leaks and a sudden loss of imaging capabilities. This failure could occur during diagnostic or surgical procedures. No injuries or incidents have been reported to date.
An oil leak in the X-ray tube can cause the system to lose its ability to provide fluoroscopic imaging. This unexpected failure during a surgical or interventional procedure could lead to significant delays or the need for alternative imaging solutions while a patient is under care.
Recall #: Z-0703-2025. Mobile fluoroscopic system providing volumetric reconstructions.
Recall #: Z-0704-2025. Mobile system providing fluoroscopic and digital spot images.
Recall #: Z-0705-2025. Some serial numbers manufactured prior to UDI compliance requirement.
Recall #: Z-0706-2025. Some serial numbers manufactured prior to UDI compliance requirement.
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 · 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.