GE Medical Systems Israel recalls Omni Legend PET scanners (15cm, 16cm, 21cm, 32cm models) due to potential streaking artifacts in PET clinical scans. Affected units have specific UDI and manufacturing lot numbers listed in the 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).
GE Medical Systems Israel is recalling certain Omni Legend PET scanners that may cause streaking artifacts in PET clinical scans. This issue is most noticeable in transaxial slices on the acquisition console. The problem does not cause injury but affects scan quality, so users should check if their scanner is affected.
The recall addresses a potential intermittent issue in certain Omni Legend systems that can result in streaking artifacts in PET clinical scan images. These artifacts are most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation). The issue does not cause injury but affects scan quality.
Healthcare facilities using GE Healthcare Omni Legend PET scanners (15cm, 16cm, 21cm, 32cm models) with specific UDI and manufacturing lot numbers listed in the recall are affected. Patients using these scanners for PET scans are at low risk as the issue does not cause injury.
Check if your scanner is listed in the recall by looking for specific UDI (Unique Device Identification) and manufacturing lot numbers provided in the document. The affected models include Omni Legend 15cm, 16cm, 21cm, and 32cm PET gantries with detailed UDI and lot numbers listed.
Review your scanner's model and UDI to see if it matches the affected models listed in the recall (15cm, 16cm, 21cm, 32cm Omni Legend PET gantries).
Compare your scanner's manufacturing lot number with the specific numbers listed in the recall to confirm if it is affected.
No, the issue does not cause injury but may result in streaking artifacts in PET clinical scan images, which can affect scan quality.
Check your scanner's UDI and manufacturing lot number against the specific numbers listed in the recall document for affected models (15cm, 16cm, 21cm, 32cm Omni Legend PET gantries).
The recall does not require immediate action, but you should check if your scanner is affected by reviewing the UDI and manufacturing lot numbers listed in the recall.
We’ve drafted a message you can send GE Medical Systems Israel to request your refund or repair — edit it as you like.
Subject: Recall Z-1112-2026 — GE Medical Systems Israel GE Medical Systems Israel Hello, I own a GE Medical Systems Israel that is covered by recall Z-1112-2026 from GE Medical Systems Israel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
