Ingenia Ingenia Elition X (REF 782107)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838098336), received between Jun 19, 2025 and Feb 4, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

11 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. 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-3311-2026 · 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-3239-2026 · 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-1963-2026 · 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-1212-2026 · 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-2211-2025 · 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-1803-2025 · Root cause: Software design · FDA record ↗

7. Sep 3, 2024Open, 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 · FDA record ↗

8. Mar 12, 2024Open, Classified

   Patient support table floor plate may be incorrectly installed.

   Z-1571-2024 · Root cause: Process design · 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-2395-2023 · Root cause: Under Investigation by firm · 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-2398-2023 · Root cause: Under Investigation by firm · 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-0460-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT AFTER THE MRI EXAMINATION WAS COMPLETED AND THE BED WAS PULLED OUT, SLEEPING PATIENT WOKE UP AND RAISED HIS HEAD WHILE THE IN-BORE MIRROR WAS STILL ATTACHED, CAUSING CONTACT WITH THE MIRROR AND INJURING HIS RIGHT EYE. THE PATIENT WAS SEEN BY A PROVIDER IN THE FACILITY AND WAS PRESCRIBED EYE DROPS TO TREAT CONJUNCTIVAL HEMORRHAGE IN THE RIGHT EYE. EYE DROPS PRESCRIBED BY A PHYSICIAN MEET THE CRITERIA FOR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. THE PATIENT WAS LATER OBSERVED AT OPHTHALMOLOGY DEPARTMENT. IT WAS REPORTED, THE PATIENT DID NOT HAVE VISION ABNORMALITIES. THE PATIENT CONDITION IS CURRENTLY UNDER OBSERVATION AFTER BEING EXAMINED BY AN OPHTHALMOLOGIST. THE REPORTED INJURY MEETS THE CRITERIA FOR A SERIOUS INJURY.

  Patient problems: Eye Injury

  MAUDE report 24255730 ↗
• MalfunctionOct 28, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A HEATING SENSATION, SKIN REDDENING AND BLISTERING WAS NOTED ON THE RIGHT SHOULDER AREA. THE BLISTER AREA IS DESCRIBED AS TOP OF RIGHT SHOULDER AND SHOULDER BLADE/SCAPULA AREA. SIZE APPROXIMATELY 0.5-1 IN. MINOR WITH REDNESS AND POTENTIAL BLISTER. CUSTOMER QUESTIONED BUT UNKNOWN REGARDING BLISTER. THE PATIENT WAS SENT TO ONSITE CLINIC AND SENT HOME. NO FOLLOW-UP REQUIRED. THE BURN IS EXPECTED TO HEAL. THE INJURY REPORTED MEETS THE CRITERIA FOR A NON-SERIOUS MINOR INJURY.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 23400852 ↗
• MalfunctionSep 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT ABOUT BURN MARKS ON AXIS Z OF GRADIENT COIL. DURING SCAN, AN USER MESSAGE DISPLAYED SMOKE DETECTOR ALARM. UPON OPENING THE REAR COVER, A VISUAL INSPECTION REVEALED BURN MARKS ON THE AXIS Z BUSBAR CONNECTED TO THE GRADIENT COIL. NO HARM WAS REPORTED RELATED TO THIS INCIDENT. BASED ON THIS EVIDENCE IT WAS DECIDED TO REPORT THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071146 ↗
• MalfunctionSep 16, 2025Sparking; Insufficient Device Problem Information; Sparking; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT ABOUT BROKEN BUSBAR. DURING SCANNING A GRADIENT ERROR CAUSED AN INTERLOCK. BASED ON THIS EVIDENCE, THE INCIDENT WAS REPORTED. IT WAS FOUND THAT THE BUSBAR OF Z AXIS WAS BURNED AND BROKEN. NO HARM WAS REPORTED RELATED TO THIS INCIDENT. BASED ON THIS EVIDENCE IT WAS DECIDED TO REPORT THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060857 ↗
• InjuryJun 19, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT THE PATIENT SUSTAINED AN APPROXIMATE 21 CM BURN (THIRD DEGREE) TO HER LEFT HIP AREA DURING A LUMBAR EXAM IN THE HEADFIRST SUPINE POSITION. THE BURN IS DESCRIBED AS IRREGULAR CIRCULAR SHAPED OPEN AREA WOUND WITH AREAS THAT APPEAR TO BE BURNED THROUGH SEVERAL LAYERS OF SKIN. THE PATIENT HAS A HISTORY OF DIABETES, OBESITY, HYPERTENSION AND IS ON ANTICOAGULANT THERAPY. THE PATIENT IS REPORTED TO BE UNDERGOING TREATMENT OF THE BURN.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22292180 ↗