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Ingenia Ingenia Elition X (REF 782119)Recalls & reported problems

Philips Medical Systems Nederland B.V. · The Ingenia Elition X with the gradient and RF designs, as well as Compressed SENSE delivers on superb image quality, improves patient handling setup time and combines this with accelerations in both 2D- and 3D scanning. · 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. 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-2211-2025 · Root cause: Device Design · Recall details · FDA record ↗

  4. Sep 3, 2024Class IIOpen, Classified

    Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.

    Z-3200-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  5. Mar 12, 2024Class IIOpen, Classified

    Patient support table floor plate may be incorrectly installed.

    Z-1571-2024 · Root cause: Process design · Recall details · FDA record ↗

  6. Jun 12, 2023Class IIOpen, Classified

    The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

    Z-2395-2023 · Root cause: Under Investigation by firm · 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-0460-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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Sources and updates

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