GE Healthcare recalled 364 Omni Legend systems on December 24, 2025, after reports of image quality issues. The recall affects multiple models distributed worldwide, including the Omni Legend 16 and 21. Users should stop using the devices immediately due to potential diagnostic inaccuracies.
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING or your healthcare provider for instructions. Notification method: Letter
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The GE Healthcare Omni Legend is a medical imaging device used for Positron Emission Tomography (PET) scans. Healthcare providers utilize these systems for diagnostic imaging to identify various medical conditions.
The hazard arises from a potential intermittent issue that creates streaking artifacts in the clinical images produced by the device. This can lead to misinterpretations of scan results, affecting patient diagnosis and treatment.
This recall is not part of a broader industry pattern.
The recall affects diagnostic capabilities of healthcare providers and may delay patient care. Users should act promptly to avoid relying on potentially inaccurate imaging.
Model numbers and serial numbers are typically found on the device label or manufacturer's plate, usually located on the back or bottom of the unit.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep records of all communications regarding the recall, including emails and phone call logs, as well as any correspondence from GE Medical Systems.
The recall includes multiple models sold under the Omni Legend name, such as Omni Legend 16, 21, and 32. The devices were distributed worldwide, including in the US, Canada, and several European and Asian countries. They were sold primarily through healthcare providers.
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