Ingenia Ingenia 1.5T (REF 781341)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00884838055322), received between Feb 6, 2018 and May 13, 2026 — classified as 16 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (8 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-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. 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 ↗

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-2411-2021 · 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-2342-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A BLISTER ON A LEFT INDEX FINGER SHORTLY AFTER THE EXAMINATION. A MALE PATIENT, 40 YEARS OLD, WAS POSITIONED FEET FIRST, SPINE, FOR PELVIS AND LUMBAR SPINE EXAMINATION WITH THE ANTERIOR ARRAY COIL. IT WAS REPORTED THE PATIENT WAS SEDATED OR ANESTHETIZED FOR THE SCAN. NO MEDICAL TREATMENT WAS PROVIDED. A DIGITAL PHOTO OF THE WOUND WAS PROVIDED AND IS DESCRIBED AS AN OVAL SHAPED BLISTER ON THE LATERAL SIDE OF THE INDEX FINGER AT THE AREA/LEVEL OF THE NAIL BED. THE SKIN IS INTACT. THE BLISTER AREA IS WHITEISH IN COLOR AND IS SURROUNDED BY AN AREA OF ERYTHEMA. THE SIZE OF THE BLISTER IS APPROXIMATELY 2.5-3CM. THE REPORTED BLISTER ON THE FINGER MEETS THE CRITERIA FOR A SERIOUS INJURY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25158009 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566586 ↗
• InjuryAug 1, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT THE PATIENT SUFFERED A BURN IN HIS THUMBS DURING A LUMBAR EXAMINATION. THE REPORTED BURN IS REPORTED AS SKIN REDDENING AND BLISTERING ON THE LEFT THUMB, SECOND DEGREE APPROXIMATELY 2 CM BLISTER SIZE. THE APPEARANCE OF THE BURN ONSET WAS LESS THAN ONE HOUR AFTER THE EXAMINATION. FIRST AID WAS ADMINISTERED; A DRESSING WAS PUT OVER THE WOUND. IT IS EXPECTED THAT THE PATIENT WILL FULLY RECOVER.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 22684398 ↗
• MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL IS 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 21897430 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL IS 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 21891178 ↗
• MalfunctionMar 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL IS 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 21662035 ↗
• MalfunctionNov 12, 2024Sparking; Insufficient Device Problem Information; Sparking; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT ABOUT A FAILURE OF THE GRADIENT COIL WHICH CAUSED ARTIFACTS. DURING REPLACEMENT BURN EVIDENCE WAS FOUND AT THE POINT OF THE TERMINAL CONNECTION. BASED ON THIS BURN EVIDENCE IT WAS DECIDED TO REPORT THIS INCIDENT. NO HARM WAS REPORTED RELATED TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664249 ↗
• InjuryOct 28, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT THE PATIENT HAD A BURN OF APPROXIMATELY 2.5 CM BETWEEN THE THUMB AND INDEX FINGER WHERE THE CALL BUTTON "HOSE" WAS LOCATED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20543692 ↗
• InjurySep 17, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT THE PATIENT SUFFERED A FULL THICKNESS BURN (I.E. THIRD DEGREE) AND A SECOND DEGREE BURN WITH A BLISTER >2.5 CM ON EACH INNER THIGH DIRECTLY ACROSS FROM ONE ANOTHER, DURING PELVIS EXAMINATION, USING TORSO COIL.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20236498 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT THROUGH THE MEDWATCH SYSTEM THAT A PATIENT SUFFERED A LARGE 2ND DEGREE BURN TO THE LEFT SIDE OF THE CHEST DURING A NECK AND SPINE EXAMINATION. THE PATIENT REQUIRED TREATMENT AS A RESULT OF THIS INJURY SUSTAINED. THE CUSTOMER DID NOT REPORT THIS INCIDENT THROUGH OUR REGULAR SERVICE CHANNELS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 20012445 ↗
• InjuryJul 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT A FEMALE PATIENT GOT 2ND DEGREE BURNS ON THE FINGERTIPS OF THE RIGHT HAND 2 DAYS AFTER THE EXAM.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19642682 ↗
• InjuryJul 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT A MALE PATIENT SUFFERED BURNS ON HIS LEFT THIGH AND LEFT HAND DURING AN EXAMINATION. THERE WAS A 2ND DEGREE BURN TO THE LEFT HAND EXHIBITING A 2CM BLISTER AND A REDDENING ON THE LEFT THIGH.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19641858 ↗
• MalfunctionJan 8, 2024Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  PHILIPS RECEIVED A REPORT THAT A STRETCHER WAS ATTRACTED TO THE MAGNET AND IMPACTED THE PATIENT SUPPORT WHICH THEN TOPPLED OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462572 ↗
• InjuryOct 24, 2023Electrical Overstress; Adverse Event Without Identified Device or Use Problem; Electrical Overstress; Adverse Event Without Identified Device or Use Problem

  IN THIS CASE, THE CUSTOMER REPORTED THAT LIGHTS FLICKERING (BALL LIGHTS) ONE SECTION OF THE LIGHT BULBS HAS BLOWN. THE PATIENT EXPERIENCED AN EPILEPTIC SEIZURE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: Convulsion/Seizure

  MAUDE report 17994504 ↗
• InjuryAug 23, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT A PATIENT SUFFERED LARGE, 3CM, BLISTERS ON BOTH KNEES DURING A PELVIC EXAMINATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17601783 ↗
• InjuryJul 28, 2023Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  IN THIS CASE, THE CUSTOMER REPORTED THAT A PEDIATRIC PATIENT RECEIVED A BURN WHILE UNDER GENERAL ANESTHESIA DURING A WHOLE SPINE SCAN. THE BURN WAS STATED TO BE THROUGH SKIN ¿ SKIN CONTACT (BACK OF LEFT THUMB TO LEFT THIGH). HOWEVER, THE EXTENT OF THE REPORTED INJURY (BURN) IS UNKNOWN AT THIS TIME. THIS EVENT IS CONSIDERED A REPORTABLE EVENT AND IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: Full thickness (Third Degree) Burn; Insufficient Information

  MAUDE report 17415158 ↗
• MalfunctionMar 21, 2023Insufficient 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 THAT THICK SMOKE EMANATED FROM THE GANTRY, SOURCE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583210 ↗
• InjuryNov 30, 2022Insufficient Device Problem Information; Unintended Electrical Shock; Insufficient Device Problem Information; Unintended Electrical Shock

  PHILIPS RECEIVED A REPORT THAT A TECHNICIAN RECEIVED AN ELECTRIC SHOCK DURING INSTALLATION ACTIVITIES. THE TECHNICIAN WAS TEMPORARILY HOSPITALIZED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT A FOLLOW UP WILL BE SENT ONCE AN INVESTIGATION IS COMPLETED.

  Patient problems: Electric Shock

  MAUDE report 15886278 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT ON A HEATING INCIDENT ON AN INGENIA 1.5T R SYSTEM. A MALE PATIENT WAS POSITIONED FEET FIRST SUPINE TO UNDERGO A PELVIS EXAMINATION WITH THE ANTERIOR AND POSTERIOR COIL. MORE THAN 1 HOUR AFTER THE EXAMINATION BLISTERING WAS OBSERVED IN THE GROIN AREA OF THE PATIENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15361171 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT THAT A PATIENT ALLEGEDLY SUFFERED OF TINNITUS AFTER AN EXAMINATION ON AN INGENIA 1.5T MR SYSTEM.

  Patient problems: Tinnitus

  MAUDE report 11884193 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PHILIPS RECEIVED A REPORT THAT A PATIENT ALLEGEDLY SUFFERED A PERMANENT HEARING LOSS/TINNITUS AFTER AN EXAMINATION ON AN INGENIA 1.5T MR SYSTEM.

  Patient problems: Hearing Impairment; Partial Hearing Loss

  MAUDE report 11027086 ↗
• MalfunctionJul 8, 2020No Apparent Adverse Event; No Apparent Adverse Event

  PHILIPS RECEIVED A REPORT ON A FIRE IN THE HOSPITAL WHICH DAMAGED THE MR SYSTEM.

  Patient problems: No Patient Involvement

  MAUDE report 10244162 ↗
• InjuryJul 29, 2019Temperature Problem

  PHILIPS RECEIVED A REPORT FROM A CUSTOMER RELATED TO A HEATING INCIDENT WITH THE POSTERIOR COIL ON AN INGENIA 1.5T SYSTEM. A PATIENT RECEIVED A 3 CENTIMETER BLISTER ON BOTH THE BUTTOCK AND THUMB.

  Patient problems: Burn, Thermal; Partial thickness (Second Degree) Burn

  MAUDE report 8839381 ↗
• InjuryFeb 6, 2018Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT FROM A CUSTOMER RELATED TO A PATIENT WHO FELL OFF THE PATIENT SUPPORT. THE PATIENT BROKE TWO RIBS, A BONE IN HIS WRIST AND HAD A FRACTURE IN HIS HEAD.

  Patient problems: Bone Fracture(s); Fall; Head Injury

  MAUDE report 7243464 ↗