Ingenia Evolution Upgrade 1.5T (REF 782148)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

6 FDA recall records name this device's identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 28, 2026Open, Classified

   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.

   Z-3318-2026 · Root cause: Software design · FDA record ↗

2. Aug 21, 2026Open, Classified

   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.

   Z-3235-2026 · Root cause: Software design · FDA record ↗

3. Apr 14, 2026Open, Classified

   The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

   Z-1954-2026 · Root cause: Under Investigation by firm · FDA record ↗

4. Dec 3, 2025Open, Classified

   The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

   Z-1204-2026 · Root cause: Software design · FDA record ↗

5. Jun 30, 2025Open, Classified

   The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

   Z-2202-2025 · Root cause: Device Design · FDA record ↗

6. May 13, 2025Open, Classified

   Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

   Z-1793-2025 · Root cause: Software design · FDA record ↗