FDA recall, , Moderate risk
GE Healthcare Omni Legend PET Scanners
Omni Legend systems may show a streaking artifact in PET scan images.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems Israel, Functional Imaging, based in Haifa, Israel, is recalling certain GE Healthcare Omni Legend systems, including OMNI Legend 16, Omni Legend 21, OMNI Legend 32, and Omni Legend PET Gantry models, due to a potential intermittent issue that can result in a streaking artifact in PET clinical scan images.
The artifact is most easily identified in transaxial slices on the acquisition console, both corrected and non-corrected for attenuation. The recall affects 364 units and was initiated on December 24, 2025.
The products were distributed worldwide, including US Nationwide and other locations. The recall was added to the FDA's Enforcement Report on January 16, 2026, and in FDA's weekly enforcement report on January 28, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
GE Healthcare Omni Legend, sold under
- UDI-DI
- 00195278454218
- 00195278592309
- 00195278792822
- 00195278901439
Recall details
- Company began the recall
- Sold in
Worldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, United Kingdom, and Uzbekistan.
- Company
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGHaifa, Israel
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98269
- Recall number
- Z-1112-2026
- Quantity recalled
- 364 units
All recalls from GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
