Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1112-2026 — GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global

U.S. FDA — Device Enforcement · Israel · 2025-12-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1112-2026
Date of alert: 2025-12-24
Country / jurisdiction: Israel
Risk level: Class II
Risk type: recall
Brand: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00195278454218

Reported risk: 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).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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