Quick Facts at a Glance
- Recall Date
- December 24, 2025
- Hazard Level
- HIGH
- Brand
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product type
- Tomography, Computed, Emission
- Model numbers
- OMNI Legend 16: UDI (01)00195278454218(21)OM3D31087(11)240400, Manufacturing Lot/Serial Number OM3D31087, OMNI Legend 16: UDI (01)00195278454218(21)OM3D31071(11)240200, Manufacturing Lot/Serial Number OM3D31071, OMNI Legend 16: UDI (01)00195278454218(21)OM3D31100(11)240700, Manufacturing Lot/Serial Number OM3D31100, OMNI Legend 16: UDI (01)00195278454218(21)OM3E31115(11)250100, Manufacturing Lot/Serial Number OM3E31115 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 24, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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).
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects diagnostic capabilities of healthcare providers and may delay patient care. Users should act promptly to avoid relying on potentially inaccurate imaging.
Practical Guidance
How to identify if yours is affected
- Locate the model number on your device.
- Check if the model number matches any listed in the recall information.
- Contact your healthcare provider for confirmation.
Where to find product info
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.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact GE Medical Systems Israel directly for assistance.
- Document your communications with the healthcare provider.
How to prevent similar issues
- Ensure medical devices have current certifications and safety approvals before purchase.
- Regularly check for any recalls or safety notices affecting medical devices.
- Consult with healthcare providers about the latest technology and safety records.
Documentation advice
Keep records of all communications regarding the recall, including emails and phone call logs, as well as any correspondence from GE Medical Systems.
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Product Details
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.
Key Facts
- Affected models include Omni Legend 16, 21, 32
- Potential for diagnostic inaccuracies due to image artifacts
- Worldwide distribution including US and Europe
- Immediate cessation of use required
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Safety Guide
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