Ingenia Elition S and Ingenia Elition X: recall status

⚠ Recalls found. Ingenia Elition S and Ingenia Elition X is named in 2 official recalls in our current data:

• FDA Class II recall Z-3311-2026 — When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
• FDA Class II recall Z-3239-2026 — A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.