Ingenia Ingenia 1.5T (REF 781396)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00884838009820), received between Mar 17, 2020 and Apr 17, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (10 reports).

8 FDA recall records name this device's identifier, 8 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. 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-1206-2026 · 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-2204-2025 · 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-1795-2025 · Root cause: Software design · Recall details · FDA record ↗

7. 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 ↗

8. Jan 6, 2022Class IIOpen, 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-0973-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT INVOLVING A PATIENT WHO UNDERWENT A LUMBAR SPINE MRI IN THE FEET FIRST SUPINE POSITION. THE PATIENT WAS CENTERED SLIGHTLY LOWER THAN LOWER COASTAL MARGINS AS IT WAS DIFFICULT TO ASSESS DUE TO THE PATIENT'S HIGH BMI. IT WAS REPORTED, DURING THE SCAN, PATIENT COMPLAINED OF BURNING SENSATION NEAR THE RIGHT THIGH, THE STAFF WENT IN AND PLACED PADS EITHER SIDE TO PROTECT THEM FROM CONTACT WITH THE BORE. PATIENT SAID THAT HELPED AND WAS HAPPY TO CONTINUE. THE PATIENT'S BODY AND BORE WALL WERE INITIALLY TOUCHING AND THEN THE PADS WERE PLACED AFTER THE FIRST SEQUENCE. DURING THE REST OF THE SCAN AND RIGHT AFTER THE SCAN, THE PATIENT DID NOT COMPLAIN OF ANY FURTHER ISSUES. HEATING SENSATION IS REPORTED AND THE BURN IS REPORTED AS A SECOND DEGREE BURN WITH A 3 TO 4 CM SIZE BLISTER. THE APPEARANCE OF THE BLISTER WAS MORE THAN ONE HOUR AFTER THE EXAM. THE WOUND WAS CLEANED AND DRESSED THE NEXT DAY WHEN THE PATIENT PRESENTED. IT IS EXPECTED THE INJURY WILL HEAL COMPLETELY. THE REPORTED BURN AND BLISTER OF 3 TO 4 CM MEETS THE CRITERIA FOR A SERIOUS INJURY.

  Patient problems: Burn(s); Burning Sensation; Partial thickness (Second Degree) Burn; Skin Burning Sensation

  MAUDE report 24910158 ↗
• MalfunctionSep 5, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  PHILIPS RECEIVED A REPORT OF A GRADIENT COIL ISSUE, INDICATING THAT THERE WAS A FIRE, ON AN ADULTERATED MR SYSTEM. THE INCIDENT OCCURRED AFTER THE SYSTEM WAS REMOVED FROM ITS ORIGINAL SITE AND RE-INSTALLED IN A MOBILE TRAILER BY AN UNAUTHORIZED THIRD PARTY, WITHOUT PHILIPS¿ KNOWLEDGE OR INVOLVEMENT. 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 22975596 ↗
• MalfunctionFeb 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL DAMAGED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21491550 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT IN WHICH A PATIENT CLAIMED TO HAVE SUSTAINED A RUPTURED EARDRUM AS A RESULT OF AN MR EXAMINATION. THE PATIENT REPORTED NO ISSUES DURING OR AFTER THE EXAMINATION. SHE CONTACTED THE HOSPITAL THE DAY AFTER TO REPORT THAT HER DOCTOR HAD DIAGNOSED THE REPORTED INJURY.

  Patient problems: Unspecified Ear or Labyrinth Problem

  MAUDE report 18853890 ↗
• InjuryMar 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT IN WHICH A PATIENT CLAIMED TO HAVE SUSTAINED A RUPTURED EARDRUM AS A RESULT OF AN MR EXAMINATION.

  Patient problems: Unspecified Ear or Labyrinth Problem

  MAUDE report 18814680 ↗
• InjuryMay 25, 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 HER THIGH AFTER A SPINAL EXAMINATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17001754 ↗
• InjuryMay 3, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT A PATIENT SUFFERED A 2ND DEGREE BURN OF ABOUT 25-30MM ON THE INSIDE OF THIGHS DURING AN EXAMINATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16858751 ↗
• MalfunctionMar 15, 2023Electrical Overstress; Insufficient Device Problem Information; Electrical Overstress; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THE POWER CABLE CONNECTION IS CRACKED AND MELTED. THE DEVICE WAS IN CLINICAL USE AT THE TIME, THE PATIENT WAS SAFELY REMOVED FROM THE SCANNER. AS A RESULT, A LOT OF SMOKE DEVELOPMENT AND AN EVACUATION OF THE DEPARTMENT, THE FIRE DEPARTMENT WAS DISPATCHED TO THE CUSTOMER SITE. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16543382 ↗
• InjuryJan 18, 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 SUSTAINED A 2ND DEGREE BURN WITH SKIN DAMAGE AFTER A LUMBAR SPIN EXAMINATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16193690 ↗
• InjuryJan 10, 2022Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT ON A HEATING INCIDENT ON AN INGENIA .5T MR SYSTEM. A PATIENT SUFFERED A 2ND DEGREE BURN ON HIS LEFT ARM AFTER AN EXAMINATION THAT WAS PERFORMED UNDER GENERAL ANESTHESIA. THE PATIENT GOT TREATED - WE ARE WAITING FOR FURTHER DETAILS FROM THE HOSPITAL.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 13203156 ↗
• InjuryAug 6, 2021Improper 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. A PATIENT SUFFERED 2ND DEGREE BURNS ON BOTH THUMBS AND BOTH THIGHS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 12286538 ↗
• InjuryMar 1, 2021Improper 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 11393218 ↗
• InjuryJan 8, 2021Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11138927 ↗
• InjuryMar 17, 2020Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HEATING FORM WAS SEND TODAY TO CUSTOMER. ACTUALLY THE EVENT DATE IS UNKNOWN, WAITING INFORMATION FROM CUSTOMER. TRANSLATION OF THE ATTACHED EMAIL: GOOD MORNING, (B)(6), THANK YOU FOR THE CONFIRMATION OF THE SOFTWARE VERSION WITHOUT ANY CONNECTION,(B)(6) ALERTED ME TO THE OCCURRENCE OF TWO VERY CLOSE CASES OF BURNS ON THE LEFT SIDE OF THE PATIENT, IN THE NORMAL DIRECTION. 1ST CASE OF PROVEN BURNS ON THE BREAST, OBESE PATIENT, PUSH BUTTON (SHIRT) IN CONTACT WITH THE MRI HOOD AND THE BREAST. MRI IN PROGRESS IT HAS TAKEN STEPS TO ISOLATE THE PATIENT'S SKIN WITH THE MRI HOOD. NO ANTENNA ELEMENTS (FLEXIBLE ANTENNA) ARE IN CONTACT WITH THE PATIENT. I AM ASKING FOR YOUR OPINION. CAN WE RULE OUT THE HYPOTHESIS OF HEATING AT THE LEVEL OF A GRADIENT COIL? OF ANOTHER COMPONENT? DO YOU HAVE ANY INTERNAL PROBES? A MONITORING OF THE TEMPERATURE OR POWER CONSUMPTION OF A COMPONENT LOCATED AT THIS LOCATION? HOW COULD WE PROVE THE ABSENCE/PRESENCE OF INTERNAL HEATING ON MRI? YOUR ELEMENTS SHOULD ALLOW US TO MAKE THE RIGHT HYPOTHESES. THANK YOU FOR YOUR INPUT, (B)(6). BIOMEDICAL ENGINEER OF THE (B)(4) NÎMES. MATERIAL RESOURCES DEPARTMENT / 06 35 23 32 38.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 9841492 ↗