Ingenia Ingenia 1.5T (REF 781315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838099715), received between Oct 5, 2020 and Nov 23, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).

9 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-3308-2026 · 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-3236-2026 · 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-1956-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. 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-2204-2025 · Root cause: Device Design · Recall details · FDA record ↗

5. May 13, 2025Class IIOpen, Classified

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

   Z-1795-2025 · Root cause: Software design · Recall details · FDA record ↗

6. May 3, 2024Class IIOpen, 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-1845-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Mar 12, 2024Class IIOpen, Classified

   Patient support table floor plate may be incorrectly installed.

   Z-1563-2024 · Root cause: Process design · Recall details · FDA record ↗

8. Aug 11, 2021Class IICompleted

   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-2412-2021 · Root cause: Device Design · Recall details · FDA record ↗

9. Jul 30, 2021Class IITerminated

   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-2341-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2022Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPOT ON A HEATING INCIDENT. PATIENT CLAIMS BURN FROM ANTERIOR COIL DURING AN MR EXAMINATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15852349 ↗
• InjuryJan 11, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT WAS POSITIONED ON THE TABLE TOP ON THE MRI FLEX TRACK BY 2 OPERATORS. THEN THE PATIENT AND THE FLEX TRACK AND TABLE TOP WERE POSITIONED ABOVE THE BASE OF THE MRI BED. AFTER THIS THE MRI BED WAS RAISED UP. DURING THIS UPWARD MOVEMENT OF THE BED THE PATIENT LEFT HER HAND HANGING BETWEEN THE FLEX TRACK AND THE BASE OF THE MRI BED. THIS WAS NOT NOTICED BY THE OPERATORS, AS A RESULT A FINGER GOT PINCHED AND PART OF IT WAS CUT OFF. IT WAS STATED BY THE OPERATORS THAT THEY WERE WATCHING THE PATIENT FROM EITHER SIDE OF THE MRI BED BUT THAT THEY HAD NOT NOTICED THE EXACT POSITION OF THE PATIENTS HAND DUE TO THE PATIENT BEING COVERED BY SHEETS.

  Patient problems: Laceration(s)

  MAUDE report 11146413 ↗
• InjuryOct 5, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT ON AN ATTRACTION INCIDENT ON AN INGENIA 1.5T MR SYSTEM. A FIRE EXTINGUISHER WAS BROUGHT INTO THE EXAMINATION ROOM, ATTRACTED TO THE MAGNET, INJURING A USER.

  Patient problems: Bone Fracture(s)

  MAUDE report 10626054 ↗