GE Healthcare has issued a Class II recall for its Omni Legend PET/CT systems following reports of image quality issues caused by a software-related artifact.
The affected systems, sold under a variety of product names and configurations, may produce streaking artifacts visible in PET clinical images. The recall was initiated on Dec. 24, 2025, and classified by the FDA on Jan. 16, 2026.
According to the FDA notice, the issue is most noticeable in transaxial image slices on both attenuation-corrected and non-corrected views. The manufacturer attributed the problem to software design flaws that can cause intermittent artifacts during scans.
Ad Statistics
Times Displayed: 255726
Times Visited: 10400
In its notification to users, GE Healthcare recommended continued use of the systems under specified safety guidelines until a correction is implemented. An URGENT MEDICAL DEVICE CORRECTION letter was sent to consignees using traceable methods. The company has advised users to contact local service representatives or GE HealthCare Service at 1-800-437-1171 with any questions or concerns.
“Patient safety is our top priority,” a GE HealthCare spokesperson told HCB News. “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 total of 364 units are included in the recall. The affected systems were distributed globally, with installations in the U.S., Europe, Asia, South America, and other regions.
The Haifa, Israel-based manufacturer, GE Medical Systems Israel – Functional Imaging, developed the Omni Legend line for emission computed tomography. The recall applies to various model configurations, including Omni Legend 16, 21, and 32, as well as PET gantry systems ranging from 15 cm to 32 cm in aperture, some of which were designed for mobile or regional deployment.
The FDA determined the cause to be related to software design. As of the most recent update, the recall remains active while GE Healthcare continues corrective actions.
More information can be found in the FDA’s medical device recall database under Recall Number Z-1112-2026.
link