Ingenia Elition SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838088108), received between Apr 11, 2024 and May 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

13 FDA recall records name this device's identifier, 11 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 16, 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-3311-2026 · Root cause: Software design · Recall details · 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-3240-2026 · Root cause: Software design · Recall details · FDA record ↗

3. 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-3239-2026 · Root cause: Software design · Recall details · FDA record ↗

4. 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-1962-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. 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-1211-2026 · Root cause: Software design · Recall details · FDA record ↗

6. 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-2210-2025 · Root cause: Device Design · Recall details · FDA record ↗

7. May 13, 2025Open, 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 ↗

8. Mar 12, 2024Open, Classified

   Patient support table floor plate may be incorrectly installed.

   Z-1570-2024 · Root cause: Process design · Recall details · FDA record ↗

9. Jun 12, 2023Open, Classified

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

   Z-2396-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. Jun 12, 2023Open, Classified

    During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

    Z-2399-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Nov 22, 2022Open, 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 ↗

12. Aug 11, 2021Completed

    When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

    Z-2418-2021 · Root cause: Device Design · Recall details · FDA record ↗

13. Jul 30, 2021Terminated

    Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

    Z-2347-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT ABOUT AN ATTRACTION INCIDENT ON AN ELITION MRI IN WHICH A HOSPITAL EMPLOYEE WAS INJURED.

  Patient problems: Hematoma

  MAUDE report 21968054 ↗
• InjuryApr 11, 2024Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  PHILIPS RECEIVED A REPORT THAT A RADIOLOGY TECHNICIAN TRIED TO CLEAN THE SACU FILTER, STUCK HER HAND IN THE VENT PIPE WHERE HER HAND GOT CAUGHT BY THE RUNNING FAN. SHE SUFFERED SERIOUS INJURIES TO 2 OF HER FINGERS , 1 OF WHICH WAS PARTIALLY AMPUTATED AS A RESULT.

  Patient problems: Laceration(s)

  MAUDE report 19085886 ↗