Ingenia Ingenia Ambition X (REF 781356)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00884838090040), received between Dec 16, 2019 and Oct 24, 2025 — classified as 8 injuries, 4 malfunctions.

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

12 FDA recall records name this device's identifier, 11 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-3310-2026 · 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-3237-2026 · 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-1961-2026 · 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-1210-2026 · 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-2209-2025 · 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-1801-2025 · 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-1851-2024 · 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-1569-2024 · Root cause: Process design · Recall details · FDA record ↗

9. 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-0975-2024 · Root cause: Device Design · Recall details · FDA record ↗

10. 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-2422-2021 · Root cause: Device Design · Recall details · FDA record ↗

11. Jul 15, 2021Class IIOpen, Classified

    The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)

    Z-0715-2024 · Root cause: Process change control · Recall details · FDA record ↗

12. Apr 23, 2021Class IIOpen, Classified

    The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

    Z-1795-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT THE PATIENT SUFFERED A BURN/BLISTER ON HIS HAND (2CM BLISTER) DURING LUMBAR SPINE SCAN. DURING THE SCAN HE DID NOT PRESS THE NURSE CALL AFTER FEELING THE SENSATION IN THE LAST SEQUENCE. THE PATIENT WAS WEARING A HOSPITAL GOWN AND UNDERWEAR AND HIS HANDS WERE AT HIS SIDE DURING THE EXAM. IT APPEARS THE LEFT HAND BELOW THE THUMB, OVER JOINT AREA THERE IS A CIRCULAR FLUID FILLED BLISTER. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT IS EXPECTED TO FULLY RECOVER. THIS REPORTED INJURY MEETS THE CRITERIA FOR SERIOUS INJURY AS THIS IS A BLISTER ON THE HAND.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23376978 ↗
• InjuryMar 27, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT FOLLOWING THE LUMBAR SCAN, THE PATIENT COMPLAINED OF A BLISTER ON THE RIGHT HAND THUMB. A 2 CM HOMOGENOUS BLISTER WAS PRESENT ON THE RIGHT THUMB, FOR WHICH NO MEDICAL TREATMENT WAS PROVIDED, AND THE BLISTER WAS EXPECTED TO HEAL.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21705598 ↗
• MalfunctionAug 21, 2024Compatibility Problem; Insufficient Device Problem Information; Compatibility Problem; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT THAT AFTER A RECENT SOFTWARE UPDATE THE IMAGE QUALITY OF THE B1000 APPEARS MUCH BRIGHTER THAN BEFORE. CUSTOMER IS WORRIED THAT THIS COULD LEAD TO MISINTERPRETATION/MISDIAGNOSIS IF THIS IS NOT RECOGNIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010896 ↗
• InjuryJul 9, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT A MALE PATIENT SUFFERED 2ND DEGREE BURNS ON HIS LEFT HAND AFTER LUMBAR SPINE EXAMINATION WITH THE CONTRAST AGENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19700577 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO PHILIPS THAT DURING AN MRI SCAN THE MIRROR USED FOR VIEWING THE TV SCREEN FELL AND INJURED THE PATIENT EYES. THE PATIENT HAD TO BE REFERRED TO THE EMERGENCY DEPARTMENT FOR AN OPHTHALMOLOGICAL EXAMINATION. THE PATIENT WAS ABLE TO LEAVE THE DEPARTMENT WITH MEDICAL TREATMENT, WITHOUT SURGERY THAT DAY. DETAILS REGARDING THE MEDICAL TREATMENT RECEIVED ARE UNKNOWN AT THIS TIME, HOWEVER THIS HAS BEEN CLASSIFIED AS A SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: Eye Injury

  MAUDE report 17283892 ↗
• InjuryJun 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A MEDWATCH REPORT (MW5115933) ABOUT AN INCIDENT WHERE AN 11 YEAR OLD GIRL HAD SUSTAINED A LARGE (3CM) 2ND DEGREE BURN ON THE RIGHT CALF OF HER LEG DURING A DOUBLE MR EXAMINATION THAT WAS PERFORMED UNDER GENERAL ANESTHESIA.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17115737 ↗
• MalfunctionMay 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER STATES THAT DESPITE FOLLOWING ALL THE SAFETY RECOMMENDATIONS OF THE IMPLANT MANUFACTURER, AND APPLYING THE RELEVANT LIMITATIONS IN THE SCANWISE TOOL, A PATIENT WITH A COCHLEAR IMPLANT REPORTED PAIN UPON ENTERING THE MRI SUITE. THE PATIENT WAS REMOVED IMMEDIATELY AND THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT. THE REPORTED PAIN IS CATEGORIZED AS A MINOR INJURY AND DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY AS NO HEALTH CONSEQUENCES WAS DOCUMENTED TO HAVE OCCURRED.

  Patient problems: Ear Pain; Implant Pain

  MAUDE report 16848080 ↗
• MalfunctionMay 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A CLINICAL ASSESSMENT PERFORMED BASED ON THE CURRENTLY AVAILABLE INFORMATION WITHIN THE COMPLAINT RECORD. THE CUSTOMER STATES THAT A PATIENT WITH A COCHLEAR IMPLANT REPORTED PAIN UPON ENTERING THE MRI SUITE. THE PATIENT WAS REMOVED IMMEDIATELY AND THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT. THE REPORTED PAIN IS CATEGORIZED AS A MINOR INJURY AND DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY AS NO HEALTH CONSEQUENCES WAS DOCUMENTED TO HAVE OCCURRED. OUT OF AN ABUNDANCE OF CAUTION WE HAVE CONCLUDED THAT THIS IS A REPORTABLE EVENT. THIS EVENT IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

  Patient problems: Ear Pain

  MAUDE report 16847139 ↗
• MalfunctionApr 28, 2023Migration; Migration

  IT WAS REPORTED THERE WAS A COCHLEAR IMPLANT DISPLACEMENT IN A 9-YEAR-OLD MALE PATIENT SCANNED ON A MR AMITION X. THE CUSTOMER REPORTED "THAT DESPITE FOLLOWING ALL THE SAFETY RECOMMENDATIONS OF THE IMPLANT MANUFACTURER, AND APPLYING THE RELEVANT LIMITATIONS IN THE SCANWISE TOOL, THE PATIENT REPORTED A LOT OF EAR PAIN AFTER PERFORMING A COUPLE OF IMAGE ACQUISITIONS. ACCORDINGLY, PATIENT HAD TO BE REMOVED FROM THE MRI ROOM QUICKLY. IMPLANT DISPLACEMENT WAS CONFIRMED, AND THE PATIENTS MOTHER MOVED THE IMPLANT BACK INTO THE APPROPRIATE POSITION. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION, HARM, OR LOSS OF HEARING RELATED TO THIS REPORTED EVENT.

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

  MAUDE report 16835830 ↗
• InjuryNov 14, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT ON A CASE OF A POTENTIAL MISDIAGNOSIS WHILST USING THE INGENIA AMBITION X MR SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 15787215 ↗
• InjuryFeb 1, 2021No Apparent Adverse Event; No Apparent Adverse Event

  PHILIPS RECEIVED A REPORT THAT A PATIENT ALLEGEDLY SUFFERED HYPERACUSIS AND TINNITUS IN BOTH EARS AFTER UNDERGOING A SPINE EXAMINATION ON AN INGENIA AMBITION X MR SYSTEM.

  Patient problems: Hearing Impairment

  MAUDE report 11257797 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem

  PHILIPS RECEIVED A REPORT FROM A CUSTOMER RELATED TO A PATIENT HEATING INCIDENT (BLISTERING ON THE RIGHT ELBOW) WITH A FLEX COIL ON AN INGENIA AMBITION X MR SYSTEM.

  Patient problems: Skin Inflammation; Skin Irritation

  MAUDE report 9472747 ↗