Ingenia 1.5T CX 781262Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838068445), received between Nov 1, 2024 and Aug 18, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).

8 FDA recall records name this device's identifier, 7 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-1957-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. May 13, 2025Class IIOpen, Classified

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

   Z-1799-2025 · Root cause: Software design · Recall details · FDA record ↗

5. 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-1846-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Jan 3, 2024Class IIOpen, Classified

   The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

   Z-0950-2024 · Root cause: Process control · Recall details · FDA record ↗

7. Oct 23, 2023Class IIOpen, Classified

   Potential component failure in the Gradient Coil could product smoke and/or fire.

   Z-0392-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. 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-2414-2021 · Root cause: Device 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.

• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50292343 ↗
• MalfunctionMar 10, 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 21558887 ↗
• MalfunctionFeb 25, 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 DAMAGED, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457174 ↗
• MalfunctionFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE SEAL IN BORE 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 21410836 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS DAMAGED AND CAME OFF. 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 21227564 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEALING RUBBER OF THE TUNNEL'S COVER 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 WAS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21227327 ↗
• MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS 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 21197356 ↗
• MalfunctionNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS DAMAGED AND NEEDED TO BE REPLACED. 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 20649907 ↗
• MalfunctionNov 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE STRIP AT THE OPENING OF THE MAGNET HAS COME 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 DAMAGED, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585462 ↗