GE Medical Systems is recalling approximately 6,944 OEC Elite and OEC 3D Mobile C-arm imaging systems because the X-ray field size may exceed the safety limit of 4% of the source-to-image distance. This mechanical defect can cause the X-ray field to be larger than the area being imaged, potentially exposing patients and healthcare staff to unnecessary radiation. The recall affects a specific group of systems with serial numbers listed in the device's technical documentation, as well as units where the service manual failed to provide the correct measurement limits.
The X-ray beam can extend beyond the intended imaging area, resulting in unintended radiation exposure to the patient's surrounding tissue or to clinical staff in the room. While no specific injuries were reported in this data, excessive radiation exposure can increase long-term health risks.
Manufacturer Repair/Correction
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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Sources: FDA iRES · Raw API Response
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