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Ingenia Ingenia Elition S (REF 782137)Recalls & reported problems

Philips Medical Systems Nederland B.V. · Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. · Class 2

All models of Ingenia (54)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

7 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
7

Summary

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

7 FDA recall records name this device's identifier, 7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Aug 28, 2026Class IIOpen, 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-3311-2026 · Root cause: Software design · Recall details · FDA record ↗

  2. Aug 21, 2026Class IIOpen, 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-3239-2026 · Root cause: Software design · Recall details · FDA record ↗

  3. Apr 14, 2026Class IIOpen, 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-1962-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  4. Dec 3, 2025Class IIOpen, Classified

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

    Z-1211-2026 · Root cause: Software design · Recall details · FDA record ↗

  5. Jun 30, 2025Class IIOpen, 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-2210-2025 · Root cause: Device Design · Recall details · FDA record ↗

  6. May 13, 2025Class IIOpen, Classified

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

    Z-1802-2025 · Root cause: Software design · Recall details · FDA record ↗

  7. Nov 22, 2022Class IIOpen, Classified

    Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

    Z-0459-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Other System, Nuclear Magnetic Resonance Imaging devices

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Sources and updates

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