FDA Issues GE HealthCare PET Scanner Recall

The U.S. Food and Drug Administration (FDA) has updated its medical device recall list to include some GE HealthCare Omni Legend systems citing the chance for the devices to create artifacts during PET exams. These artifacts pose the risk of impacting the ability to properly read and assess images.

Manufacturer Reason for Recall: 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).

FDA Determined Cause: Software design

Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/24/2025 via letter sent using traceable means. The notice explained the problem with the device, safety issue, and provided recommendations (instructions) for the safe use of the device until the correction can be made.

“Patient safety is our top priority. Hospitals can continue using their device by following instructions provided in our recall letter. We are in the process of implementing a software correction for all impacted systems. There have been no reports of patient injury as a result of this potential issue,” a GE HealthCare spokesperson said.

For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

The FDA notification indicates that 364 units are affected by the recall. These units are in operation globally, including in the United States. The recall has been categorized as Class II, which the FDA designates for issues that have the potential to “cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Those with questions or concerns regarding the issue can contact GE HealthCare Service at 800-437-1171 or reach out to their local service representative.