GE Healthcare is recalling 364 Omni Legend PET systems due to a technical issue that can cause intermittent streaking artifacts in clinical scan images. These streaks are most visible in the cross-sectional views on the system's acquisition console and appear in both corrected and non-corrected images. Because these artifacts distort medical imagery, they may interfere with a clinician's ability to provide an accurate medical diagnosis. GE Medical Systems Israel has initiated this voluntary recall to correct affected systems distributed worldwide.
The streaking artifacts can degrade the diagnostic quality of PET scans, potentially leading to medical misinterpretations or the need to repeat patient scans. No patient injuries or incidents have been reported to date, but the defect compromises the reliability of clinical data provided by the imaging system.
Manufacturer correction or technical update.
Units manufactured between April 2024 and January 2025.
Units manufactured between January 2025 and April 2025.
Units manufactured between July 2023 and April 2025.
MEA designated gantry systems.
BJ Global gantry series.
WSO series gantries.
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
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