Ingenia Ingenia Elition X (REF 781358)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00884838088115), received between Oct 16, 2019 and Sep 2, 2026 — classified as 5 injuries, 7 malfunctions.

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

14 FDA recall records name this device's identifier, 12 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. May 3, 2024Open, Classified

   The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

   Z-1852-2024 · Root cause: Under Investigation by firm · FDA record ↗

9. 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 ↗

10. 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 ↗

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 ↗

12. Jan 6, 2022Open, Classified

    Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

    Z-0974-2024 · Root cause: Device Design · FDA record ↗

13. 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-2419-2021 · Root cause: Device Design · FDA record ↗

14. 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-2344-2021 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Improper or Incorrect Procedure or Method

  Patient problems: Bruise/Contusion; Insufficient Information

  MAUDE report 50561666 ↗
• InjuryMar 31, 2026Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT THE PATIENT UNDERWENT A RIGHT SHOULDER MRI SCAN. THE PATIENT DID NOT PRESS THE NURSE CALL BUTTON DURING THE PROCEDURE. THE ANATOMIC DETAILS OF THE PATIENT VIEW WERE NOT PROVIDED. THE PATIENT WAS POSITIONED SUPINE WITH THEIR RIGHT ARM EXTERNALLY ROTATED, ROLL UNDER THEIR ARM PADDING AND HAND RAILS PUSHED IN, TO KEEP ARM IN PLACE. IT IS REPORTED THE COIL USED FOR THE EXAM WAS THE DS SHOULDER 16 CH 3.0T. THERE WERE NO SPECIFIC DETAILS PROVIDED ABOUT WHAT THE ACTUAL SHOULDER BURN/INJURY IS. THERE WERE ALSO NO DETAILS PROVIDED ON MEDICAL INTERVENTION GIVEN TO THE PATIENT. DUE TO INSUFFICIENT INFORMATION IN THIS CASE, THE SERIOUS INJURY CANNOT BE RULED OUT. THEREFORE, WE HAVE DECIDE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Burn(s); Insufficient Information; Itching Sensation; Partial thickness (Second Degree) Burn

  MAUDE report 24740635 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL WAS DAMAGE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409452 ↗
• InjuryJun 17, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT DURING THE USE OF THE DEVICE, METAL WAS ATTRACTED FROM THE OUTSIDE, RESULTING IN INJURIES OF THE HOSPITAL STAFF. FIELD SERVICE ENGINEER HAS ARRIVED AT THE VENUE AND TOGETHER REMOVED THE INJURED PERSON THROUGH SIMPLE TREATMENT. THE INJURED PERSON RECEIVED THE TREATMENT AT THE HOSPITAL ON (B)(6) 2025. THE SKIN AND MUSCLES ON THE RIGHT LOWER LEG WERE INJURED AND BLEEDING, THE EXTEND OF WHICH COULD NOT BE CONFIRMED. THERE IS NO MORE DETAILED INFORMATION ABOUT THE REPORTED EVENT OF THE HARMED USER. BASED ON INFORMATION AVAILABLE AT THE TIME OF THIS REPORT SUBMISSION, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THE REPORTED HARM MEETS CRITERIA FOR SERIOUS INJURY. THEREFORE, WE REPORT THIS INCIDENT OUT OF CAUTION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22236702 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT THAT A FEMALE PATIENT SUFFERED A BURN OF UNKNOWN SEVERITY TO HER HAND DURING AN MR EXAMINATION OF THE LUMBAR SPINE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21216991 ↗
• MalfunctionApr 25, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT ALLEGEDLY A MISDIAGNOSIS HAD OCCURRED DUE TO AN IMAGE QUALITY ISSUE. DURING A POST CONTRAST STUDY A MALIGNANT PROCESS DID NOT SHOW UP ENHANCING ENOUGH AS ANTICIPATED WHICH LEAD TO A WRONG DIAGNOSIS. THIS COULD LEAD TO THAT THE DIAGNOSIS AND TREATMENT HAS TO BE ALTERED WITH POTENTIAL LONG TERM EFFECTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19180042 ↗
• MalfunctionApr 25, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT ALLEGEDLY A MISDIAGNOSIS HAD OCCURRED DUE TO AN IMAGE QUALITY ISSUE. DURING A POST CONTRAST STUDY A MALIGNANT PROCESS DID NOT SHOW UP ENHANCING ENOUGH AS ANTICIPATED WHICH LEAD TO A WRONG DIAGNOSIS. THIS WAS SUBSEQUENTLY DISCOVERED DURING A SURGICAL PROCEDURE AFTER WHICH THE DIAGNOSIS AND TREATMENT HAD TO BE ALTERED WITH POTENTIAL LONG TERM EFFECTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19179390 ↗
• MalfunctionDec 5, 2023Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  PHILIPS RECEIVED A REPORT OF AN ATTRACTION INCIDENT WITH AN ANESTHESIA CART THAT WAS BROUGHT INTO THE EXAMINATION ROOM. THIS CAUSED EXTENSIVE DAMAGE TO THE MR SYSTEM AND CAUSED THE PATIENT SUPPORT TO TOPPLE OVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264888 ↗
• MalfunctionMay 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT A FLOORPLATE WAS NOT INSTALLED ACCORDING TO SPECIFICATIONS AND HAD PARTLY DETACHED FROM THE FLOOR. IT WAS GLUED TO THE BUILDING INSTEAD OF BOLTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029502 ↗
• MalfunctionApr 5, 2022Electrical Overstress; Insufficient Device Problem Information; Electrical Overstress; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT AN INGENIA ELITION MR SYSTEM CAUGHT FIRE DURING A TEST SCAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14016102 ↗
• MalfunctionFeb 19, 2020Fire; Fire

  PHILIPS RECEIVED A REPORT ON A FIRE INCIDENT WITH THE MAGNET OF AN INGENIA ELITION X MR SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9726343 ↗
• InjuryOct 16, 2019Patient-Device Incompatibility

  PHILIPS RECEIVED A REPORT THAT A NON-COMPATIBLE MR WHEELCHAIR WAS BROUGHT IN THE EXAMINATION ROOM. THE WHEELCHAIR WAS ATTRACTED TO THE MAGNET, AND THE ATTENDING NURSE GOT A CUT AT THE EYEBROW, REQUIRING STITCHES.

  Patient problems: Laceration(s)

  MAUDE report 9196393 ↗