Ingenia Ingenia 3.0T (REF 781377)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838009813), received between Oct 21, 2019 and Oct 31, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

9 FDA recall records name this device's identifier, 9 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-3309-2026 · 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-3238-2026 · 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-1958-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Dec 3, 2025Class IIOpen, Classified

   The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

   Z-1207-2026 · Root cause: Software design · Recall details · FDA record ↗

5. 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-2206-2025 · Root cause: Device Design · Recall details · FDA record ↗

6. May 13, 2025Class IIOpen, Classified

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

   Z-1797-2025 · Root cause: Software design · Recall details · FDA record ↗

7. May 13, 2025Class IIOpen, Classified

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

   Z-1798-2025 · Root cause: Software design · Recall details · FDA record ↗

8. 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-1848-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. Mar 12, 2024Class IIOpen, Classified

   Patient support table floor plate may be incorrectly installed.

   Z-1566-2024 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT IN WHICH A PATIENT INDICATED A HEARING ISSUE, RINGING/TINNITUS, AFTER AN MR EXAMINATION. AS WE HAVE NO INFO ON THE EXTENT OF THE ISSUE IT WAS DECIDED TO REPORT THIS OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577923 ↗
• InjuryJan 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIP RECEIVED A REPORT THAT A MALE PATIENT SUFFERED A LARGE 2ND DEGREE BURN TO HIS RIGHT SHOULDER AFTER UNDERGOING AN MRI EXAMINATION OF THE LEFT SHOULDER.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18490811 ↗
• InjuryJun 19, 2023Device Handling Problem; Device Handling Problem

  PHILIPS RECEIVED A REPORT THAT A USER ACCIDENTALLY DROPPED THE TOP PART OF THE NVC HEAD COIL ONTO THE PATIENTS FACE DURING REMOVAL OF THE COIL. THE PATIENT SUSTAINED A BROKEN NOSE AS A RESULT OF THE DROP.

  Patient problems: Bone Fracture(s)

  MAUDE report 17150090 ↗
• InjuryMay 24, 2023Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT A PATIENT SUFFERED A LARGE 2ND DEGREE BURN ON THE RIGHT ELBOW AFTER AN MR EXAMINATION THAT WAS PERFORMED WHILE THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16990276 ↗
• InjuryMar 22, 2023Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT A CUSTOMER BROKE A FINGER WHEN HIS FINGER WAS CRUSHED BETWEEN THE SCANNER AND THE TROLLEY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16590273 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT A PATIENT SUFFERED FROM LONG TERM TINNITUS AFTER AN MRI EXAMINATION.

  Patient problems: Tinnitus

  MAUDE report 15649808 ↗
• InjuryDec 18, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT ON A HEATING INCIDENT ON AN INGENIA 1.5T MR SYSTEM .

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11036577 ↗
• MalfunctionJul 23, 2020No Apparent Adverse Event; No Apparent Adverse Event

  PHILIPS RECEIVED A REPORT OF A MAGNET QUENCH AFTER A FIRE IN THE VICINITY OF THE EXAMINATION ROOM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10312693 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem

  EXAM: MRI RT SHOULDER ARTHROGRAM. AFTER THE EXAM WAS 3/4 OF THE WAY COMPLETED, A FINAL SEQUENCE WAS REQUIRED TO VISUALIZE INSIDE THE JOINT SPACE OF THE SHOULDER, ABER VIEW. THE PT WAS POSITIONED WITH HIS RIGHT ARM PARTIALLY EXTENDED ABOVE HIS HEAD AND RESTED ON A PILLOW, AND ALSO STABILIZED WITH A SAND BAG. THE RIGHT ARM RESTED SOLELY ON THE PILLOW AS THE PT WAS GUIDED IN FOR THIS LAST SEQUENCE. AFTER THE 3 MIN SCAN WAS COMPLETED, AND THE PT EXITED THE SCANNER, HE MENTIONED FEELING HOT AFTER HE RESTED HIS HAND ON HIS FOREHEAD. PT ALSO MENTIONED LATER THAT AFTER HE REMOVED HIS HAND FROM TOUCHING HIS FOREHEAD, THE HEATING SENSATION STOPPED. THE PT WAS LATER SEEN BY A NURSE AND A RADIOLOGIST WHO ASSESSED HIM. THE PT WAS LATER DISCHARGED WITH INSTRUCTIONS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Alteration In Body Temperature

  MAUDE report 9218913 ↗