Ingenia Ingenia 3.0T (REF 781342)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00884838055339), received between Apr 25, 2018 and Sep 22, 2026 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

10 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-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 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 ↗

8. 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 ↗

9. 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-2417-2021 · Root cause: Device Design · Recall details · FDA record ↗

10. 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-2343-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Insufficient Device Problem Information

  Philips received a report that during an MR examination, artifacts appeared and the scan was interrupted. These artifacts turned out to be caused by a broken terminal connection on the Gradient coil. There was no sign of smoke or burning smell and no patient or users were harmed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853284 ↗
• MalfunctionJan 5, 2026Insufficient Device Problem Information; Device Handling Problem

  PHILIPS RECEIVED A REPORT THAT THE PATIENT WAS ON THE TABLE TOP AND WHEN TRYING TO REPOSITION THE PATIENT, THE TABLE TOP CAME OFF THE HEAD END OF THE TROLLEY AND FELL WITH THE PATIENT. PATIENT REMAINED ON TABLE WHEN THE ONE END DISCONNECTED. IT WAS REPORTED THE PATIENT WAS NOT HARMED. NO TREATMENT WAS NEEDED BY THE PATIENT. THE PATIENT WAS ON A VENTILATOR AND MRI BRAIN EXAM WAS COMPLETED ON THE PATIENT. THE ISSUE OCCURRED AFTER THE MRI EXAM WAS COMPLETED. THE PATIENT UNDERWENT A CT SCAN FOLLOWING THE FALL TO RULE OUT INJURY. THERE IS NO REPORT OF DETERMINISTIC EFFECTS TO THE PATIENT IN THIS CASE (E.G. SKIN REDDENING, RASH, BURN). EVEN THOUGH NO HARM TO THE PATIENT WAS REPORTED, OUT OF ABUNDANCE OF CAUTION, WE DECIDED TO REPORT THIS INCIDENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957245 ↗
• MalfunctionDec 22, 2025Sparking; Insufficient Device Problem Information; Sparking; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT ABOUT GRADIENT AMPLIFIER RACK FAULT. DURING SCANNING A GRADIENT AMPLIFIER RACK FAULT ERROR WAS REPORTED. A CURRENT ERROR IN Z2 WAS SEEN AND GC TERMINAL WAS BROKEN. BASED ON THIS EVIDENCE, THE INCIDENT WAS REPORTED. 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 23863917 ↗
• MalfunctionDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT NOTIFICATION VIA THE DANISH MEDICINES AGENCY. PROBLEM DESCRIPTION AS FOLLOWS: "THE PATIENT HAD AN UNPLEASANT EXPERIENCE DURING AN MRI SCAN ON (B)(6) 2024. SHE FELT DIZZY AND A BURNING SENSATION IN HER WHOLE HEAD AND NECK, EYES, FACE, AND MOUTH. TINGLING THROUGHOUT HER BODY, ESPECIALLY IN HER HANDS AND ARMS. ITCHING ALL OVER HER BODY. INVOLUNTARY TWITCHING AND TREMORS; INSIDE THE SCANNER, EXPERIENCED A DRY FACE, MOUTH, AND EYES. AFTER SCANNING, THE PATIENT FELT CONFUSED, ENDED UP IN THE WRONG PLACE, DIDN'T FEEL THAT HER BRAIN WAS WORKING, WAS FORGETFUL AFTERWARD. DRAINED OF ENERGY, RESTLESS AND STRESSED, ITCHING THROUGHOUT HER BODY, ESPECIALLY IN THE NECK. BURNING SENSATION ESPECIALLY IN THE HEAD AND NECK. 2. DAY, A LOT OF HEADACHES AND PAIN IN THE JOINTS AND MUSCLES. TENSION THROUGHOUT HER BODY. ITCHING AND SLEEP DISTURBANCES. THE 2 THINGS HAVEN'T GONE YET. SKIN PROBLEMS." IT IS NOT KNOWN IF THE PATIENT'S SYMPTOMS HAVE FULLY RESOLVED OR, THERE WAS ANY TREATMENT REQUIRED. BASED ON THE AVAILABLE INFORMATION AND OUT OF ABUNDANCE OF CAUTION, WE DECIDED TO BE REPORTED THIS EVENT.

  Patient problems: Confusion/ Disorientation; Insufficient Information; Itching Sensation

  MAUDE report 23836176 ↗
• InjuryJun 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED SKIN REDDENING AND TWO SMALL BLISTERS (APPROXIMATELY 10 MM EACH) ON THE RIGHT INDEX FINGER. THE PATIENT WAS UNDERGOING AN ABDOMINAL PROCEDURE IN HEADFIRST, SUPINE POSITION. NO MEDICAL TREATMENT WAS ADMINISTERED. THE PATIENT WAS NOT UNDER SEDATION. THE REPORTED REDDENED AREA WITH TWO SMALL BLISTERS MEETS THE CRITERIA FOR A SERIOUS INJURY AS THE REPORTED BURN IS ON THE PATIENT'S HAND.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22326622 ↗
• InjuryMay 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT ABOUT AN ATTRACTION INCIDENT ON AN INGENIA 3.0T IN WHICH A HOSPITAL EMPLOYEE WAS INJURED. AS THE SEVERITY OF THE INJURY WAS NOT DISCLOSED IT WAS DECIDED TO REPORT OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Bruise/Contusion

  MAUDE report 22000235 ↗
• MalfunctionMar 20, 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. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650885 ↗
• MalfunctionMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT A GRADIENT RACK FAULT OCCURRED. UPON CLOSURE INSPECTION IT WAS FOUND THAT THE ZB+ TERMINAL WAS BROKEN. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616750 ↗
• MalfunctionDec 28, 2023Electrical Overstress; Insufficient Device Problem Information; Electrical Overstress; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT ON AN INCIDENT WHERE THERE WAS SMOKE COMING FROM THE SYSTEM, BOTH IN THE TECHNICAL ROOM AND THE EXAMINATION ROOM. THERE WAS NO VISIBLE FIRE. THE PATIENT WAS EVACUATED IN TIME BUT 2 HOSPITAL WORKERS SUFFERED MINOR SMOKE INHALATION ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408267 ↗
• InjuryOct 3, 2023Adverse 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 ALLEGEDLY SUFFERED HEARING DAMAGE FROM THE PATIENT INFOTAINMENT SYSTEM USED DURING SCANNING.

  Patient problems: Hearing Impairment

  MAUDE report 17860156 ↗
• MalfunctionMar 18, 2023Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT THE TABLE FLOOR PLATE FOR THE MRI WAS INCORRECTLY INSTALLED. IT WAS IDENTIFIED THAT THE TABLE FLOOR PLATE WAS GLUED INTO THE TIMBER FLOOR INSTEAD OF THROUGH BOLTED AND ANCHORED TO THE CONCRETE STRUCTURAL FLOOR. THERE IS POTENTIAL FOR THE TABLE TO BECOME DISLODGED FROM THE BASE AND ALLOWING FOR MOVEMENT OR TIPPING OF THE TABLE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DETERMINED TO BE REPORTABLE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570178 ↗
• MalfunctionMar 18, 2023Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT THE TABLE FLOOR PLATE FOR THE MRI WAS INCORRECTLY INSTALLED. IT WAS IDENTIFIED THAT THE TABLE FLOOR PLATE WAS GLUED INTO THE TIMBER FLOOR INSTEAD OF THROUGH BOLTED AND ANCHORED TO THE CONCRETE STRUCTURAL FLOOR. THERE IS POTENTIAL FOR THE TABLE TO BECOME DISLODGED FROM THE BASE AND ALLOWING FOR MOVEMENT OR TIPPING OF THE TABLE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DETERMINED TO BE REPORTABLE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569497 ↗
• MalfunctionMar 18, 2023Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT THE TABLE FLOOR PLATE FOR THE MRI WAS INCORRECTLY INSTALLED. IT WAS IDENTIFIED THAT THE TABLE FLOOR PLATE WAS GLUED INTO THE TIMBER FLOOR INSTEAD OF THROUGH BOLTED AND ANCHORED TO THE CONCRETE STRUCTURAL FLOOR. THERE IS POTENTIAL FOR THE TABLE TO BECOME DISLODGED FROM THE BASE AND ALLOWING FOR MOVEMENT OR TIPPING OF THE TABLE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DETERMINED TO BE REPORTABLE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569477 ↗
• MalfunctionMar 18, 2023Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT THE TABLE FLOOR PLATE FOR THE MRI WAS INCORRECTLY INSTALLED. IT WAS IDENTIFIED THAT THE TABLE FLOOR PLATE WAS GLUED INTO THE TIMBER FLOOR INSTEAD OF THROUGH BOLTED AND ANCHORED TO THE CONCRETE STRUCTURAL FLOOR. THERE IS POTENTIAL FOR THE TABLE TO BECOME DISLODGED FROM THE BASE AND ALLOWING FOR MOVEMENT OR TIPPING OF THE TABLE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DETERMINED TO BE REPORTABLE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569354 ↗
• MalfunctionMar 17, 2023Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT THE TABLE FLOOR PLATE FOR THE MRI WAS INCORRECTLY INSTALLED. IT WAS IDENTIFIED THAT THE TABLE FLOOR PLATE WAS GLUED INTO THE TIMBER FLOOR INSTEAD OF THROUGH BOLTED AND ANCHORED TO THE CONCRETE STRUCTURAL FLOOR. THERE IS POTENTIAL FOR THE TABLE TO BECOME DISLODGED FROM THE BASE AND ALLOWING FOR MOVEMENT OR TIPPING OF THE TABLE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DETERMINED TO BE REPORTABLE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569246 ↗
• MalfunctionMar 15, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SYSTEM ARRIVED ON SITE FOR INSTALLATION WITH THE INCORRECT LIFTING BOLTS ATTACHED. THESE INCORRECT LIFTING BOLTS WERE RATED FOR A 1.5T SYSTEM BUT NOT FOR A 3.0T SYSTEM. THERE WAS NO HARM AS A RESULT OF THIS EVENT. IF THIS ISSUE WERE TO RECUR AND INADEQUATELY RATED LIFTING BOLTS WERE USED DURING AN INSTALLATION AND WOULD FAIL, THERE WOULD BE POTENTIAL FOR SERIOUS INJURY OR DEATH. THEREFORE, THIS EVENT IS DETERMINED TO BE REPORTABLE. A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549201 ↗
• InjuryJun 29, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  EXAMINATION USING A BREASTCOIL CAUSED PAIN IN THE SIDE. EXAMINATION USING A BREAST COIL CAUSED PAIN IN THE SIDE. A CUSHION WAS PLACED ON THE BREST COIL, BUT THE PATIENT WAS INJURED.

  Patient problems: Bone Fracture(s)

  MAUDE report 14852387 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT OF A PATIENT WHO CLAIMED TO HAVE SUSTAINED HEARING LOSS FOLLOWING AN MR EXAMINATION.

  Patient problems: Partial Hearing Loss

  MAUDE report 12560572 ↗
• InjuryMay 21, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT FROM A CUSTOMER STATING THAT A PATIENT'S LEG WAS ATTRACTED IN THE MAGNET BORE DURING AN EXAMINATION BECAUSE OF ITS METAL IMPLANTS. THIS RESULTED IN THE NEED FOR REFIXATION OF THE PATIENT'S LEG IMPLANT.

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

  MAUDE report 11864024 ↗
• InjuryApr 29, 2019Electromagnetic Interference

  ASSISTANT DOCTOR MOVED A MAGNETIC ASPIRATOR INTO RF ROOM. THIS ASPIRATOR WAS ATTRACTED TO THE MR SYSTEM. THE ANESTHETIST'S LEG WAS BETWEEN THE ASPIRATOR AND THE MR SYSTEM, WHICH RESULTED IN A BROKEN LEG.

  Patient problems: Bone Fracture(s)

  MAUDE report 8560262 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT A FEMALE PATIENT SUSTAINED A BLISTER OF APPROXIMATELY 4X8 CM ON THE LEFT HIP. JUST BEFORE THE PATIENT HAD HAD A LUMBAR EXAMINATION ON AN INGENIA 3.0T.

  Patient problems: Swelling

  MAUDE report 7457662 ↗