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 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.
Certain Omni Legend systems may produce a streaking artifact in PET scan images, which can compromise diagnostic accuracy. This issue is most noticeable in transaxial slices on the acquisition console.
No specific incidents of injury or patient harm have been reported in relation to this recall. The potential for misdiagnosis due to image artifacts poses a significant risk.
Stop using the device immediately. Healthcare providers should follow the recall instructions provided by GE Healthcare. Contact your healthcare provider or GE Medical Systems Israel for further guidance.
For more information, contact GE Medical Systems Israel at their official website or through their customer service lines.
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