Ingenia Smartpath to dStream for 3.0T (REF 781270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00884838095083), received between Oct 29, 2024 and Jul 27, 2026 — classified as 3 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (41 reports).

11 FDA recall records name this device's identifier, 10 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-3314-2026 · 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-3243-2026 · 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-1967-2026 · 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-1216-2026 · 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-2216-2025 · 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-1789-2025 · Root cause: Software design · Recall details · FDA record ↗

7. May 13, 2025Class IIOpen, Classified

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

   Z-1790-2025 · Root cause: Software design · Recall details · FDA record ↗

8. Sep 3, 2024Class IIOpen, Classified

   Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.

   Z-3204-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. 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-1862-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. 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-0956-2024 · Root cause: Process control · Recall details · FDA record ↗

11. 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-2421-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50016494 ↗
• MalfunctionJul 22, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25901776 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) UPPER SEAL WAS BROKEN. 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 25516393 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25169529 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE SEALING RING (BODY COIL) ON THE DEVICE HAD 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 LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157177 ↗
• MalfunctionMay 12, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE FRONT RUBBER SEAL WAS DEFECTIVE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DEFECTIVE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146598 ↗
• MalfunctionApr 9, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL STRIP WAS TORN. 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 24827660 ↗
• InjuryMar 4, 2026Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT A WHEELCHAIR MADE UP OF FERROUS MATERIAL WAS BROUGHT INTO THE MR ROOM. THE USER WAS INJURED WHEN THE MAGNETIC WHEELCHAIR BECAME STUCK WHILE APPROACHING THE MAGNET. AS A RESULT, THE USER SUSTAINED BRUISES AND ABRASIONS. THE USER WAS SENT TO EMERGENCY DEPARTMENT OF HOSPITAL. THE REPORTED INJURY WAS SUPERFICIAL IN NATURE, CONSISTING ONLY OF MINOR ABRASIONS AND BRUISES, AND FULL RECOVERY IS EXPECTED. THE CUSTOMER HAS CHOSEN NOT TO PROVIDE INFORMATION REGARDING THE USER INVOLVED INCLUDING REGION, SIZE, OR LOCATION OF THE INJURY, NOR ANY INFORMATION ABOUT THE MEDICAL INTERVENTIONS PROVIDED. WE HAVE DECIDE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion; Bruise/Contusion; Insufficient Information

  MAUDE report 24510868 ↗
• InjuryMar 3, 2026Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT A WHEELCHAIR MADE UP OF FERROUS MATERIAL WAS BROUGHT INTO THE MR ROOM. THE PATIENT WAS INJURED WHEN THE MAGNETIC WHEELCHAIR BECAME STUCK WHILE APPROACHING THE MAGNET. AS A RESULT, THE PATIENT SUSTAINED BRUISES AND ABRASIONS. THE PATIENT WAS SENT TO EMERGENCY DEPARTMENT OF HOSPITAL. THE REPORTED INJURY WAS SUPERFICIAL IN NATURE, CONSISTING ONLY OF MINOR ABRASIONS AND BRUISES, AND FULL RECOVERY IS EXPECTED. THE CUSTOMER HAS CHOSEN NOT TO PROVIDE INFORMATION REGARDING THE PATIENT INVOLVED INCLUDING REGION, SIZE, OR LOCATION OF THE INJURY, NOR ANY INFORMATION ABOUT THE MEDICAL INTERVENTIONS PROVIDED. WE HAVE DECIDE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Abrasion; Bruise/Contusion; Insufficient Information

  MAUDE report 24492903 ↗
• MalfunctionFeb 4, 2026Detachment 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 24255845 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL 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 CAME OFF IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197681 ↗
• MalfunctionJan 27, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS TORN OFF (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 24187579 ↗
• MalfunctionJan 9, 2026Detachment 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 24017783 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837056 ↗
• MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678567 ↗
• MalfunctionOct 16, 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 (COME 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 LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23313670 ↗
• InjuryAug 19, 2025Device Handling Problem; Device Handling Problem

  PHILIPS RECEIVED A REPORT THAT A PATIENT WAS INJURED AND THAT THE FRACTURE WAS OF THE MIDDLE FINGER. THE DAY AFTER THE INCIDENT, THE PATIENT WAS EVALUATED AND TREATED IN THE CLINIC. THE PATIENT IS EXPECTED TO FULLY RECOVER AND THERE IS NO PHOTO OF THE PATIENT'S HAND. HOWEVER, THERE IS A VIDEO AVAILABLE EXPLAINING HOW THE INJURY OCCURRED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22838523 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL UPPER (RUBBER SEAL) WAS DAMAGED (TEAR). 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 22791757 ↗
• MalfunctionAug 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22712026 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL (RUBBER) IN THE TUNNEL 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 22673043 ↗
• MalfunctionJul 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 22552783 ↗
• MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE GANTRY RUBBER SEAL (QBC SEAL) WAS LOOSE THAT IT FELL OUT. 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/DAMAGED/MISSING IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516960 ↗
• MalfunctionJun 20, 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 22295137 ↗
• MalfunctionJun 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL (RUBBER) 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 22163593 ↗
• MalfunctionMay 19, 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 22041826 ↗