Ingenia Smartpath to dStream for 1.5T (REF 781260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 00884838095076), received between Nov 12, 2024 and Sep 28, 2026 — classified as 3 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (128 reports).

10 FDA recall records name this device's identifier, 9 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-1965-2026 · 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-1788-2025 · Root cause: Software design · Recall details · FDA record ↗

5. 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-3203-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Mar 12, 2024Class IIOpen, Classified

   Patient support table floor plate may be incorrectly installed.

   Z-1589-2024 · Root cause: Process design · Recall details · FDA record ↗

7. 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-0955-2024 · Root cause: Process control · Recall details · FDA record ↗

8. Dec 29, 2023Class IIIOpen, Classified

   An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

   Z-0812-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. Oct 23, 2023Class IIOpen, Classified

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

   Z-0395-2024 · Root cause: Under Investigation by firm · 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-2415-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Philips received a report that the bore seals were coming 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 50912346 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Philips received a report that the upper Quadrature Body Coil (QBC) seal 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 loose it is likely that this could lead to serious injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911944 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Philips received a report that the Quadrature Body Coil (QBC) seal 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 comes loose it is likely that this could lead to serious injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911659 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Philips received a report that the upper Quadrature Body Coil (QBC) seal has peeling 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 peeled it is likely that this could lead to serious injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910858 ↗
• MalfunctionSep 24, 2026Detachment of Device or Device Component

  Philips received a report that the rubber on the QBC was coming 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 50882014 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Philips received a report that the upper and lower Quadrature Body Coil (QBC) seal has 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 50797882 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component

  Philips received a report that the QBC seal cone 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 50686107 ↗
• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559151 ↗
• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291935 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219485 ↗
• MalfunctionJul 27, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50016493 ↗
• MalfunctionJul 22, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25902047 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) RUBBER SEAL ON THE FRONT CONE COVER 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 25686444 ↗
• MalfunctionMay 20, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE RUBBER SEALS IN BETWEEN THE BODY COIL AND FRONT/REAR COVERS WERE TEARING. 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 25226015 ↗
• MalfunctionMay 19, 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 25214014 ↗
• MalfunctionMay 15, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE PROTECTIVE RUBBER INSIDE THE MAGNET BORE 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 25179968 ↗
• MalfunctionMay 14, 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 25168579 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE RUBBER ON THE QUADRATURE BODY COIL (QBC) HAD 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 25157179 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE RUBBER PART THAT THE SEAL ON THE FRONT CONE OF THE MAGNET HAD PEELED 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 25122774 ↗
• MalfunctionApr 9, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL HAS 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 COMES OFF/BECOMES LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24826438 ↗
• MalfunctionApr 2, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL HAS COME OFF COMPLETELY AND 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 24764052 ↗
• MalfunctionMar 18, 2026Detachment 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 DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629284 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT A MALE PATIENT SUSTAINED A SKIN INJURY, A LACERATION WHILE ENTERING THE ACHIEVA (D STREAM) RESONATOR. THE INCIDENT OCCURRED DUE TO THE ABSENCE OF THE QUADRATURE BODY COIL SEALING ADHESIVE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS MISSING IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY. THE INJURY IS OBSERVED WITH REDNESS AND TRACES OF BLOOD. THE INJURY WAS LOCATED ON THE RIGHT FOREARM, DISTAL MIDDLE THIRD, AND MEASURED LESS THAN 1 CM. A NURSING ASSISTANT CLEANED THE AREA WITH SALINE SOLUTION AND, ONCE DRY, APPLIED FATTY ACIDS (LINOVERA TOPICAL SOLUTION). THE WOUND IS EXPECTED TO HEAL COMPLETELY AND THE PATIENT REMAINED STABLE. NO PHOTOGRAPH WAS AVAILABLE FOR ASSESSMENT. AT THE TIME OF THE INCIDENT, THE PATIENT WAS UNDERGOING A SIMPLE LUMBOSACRAL SPINE MRI UNDER GENERAL ANESTHESIA, WITH A DURATION OF 30 MINUTES. THE REPORTED INJURY MEETS THE CRITERIA FOR A MINOR NON SERIOUS INJURY, AND THE TREATMENT ADMINISTERED IS CONSIDERED FIRST AID.

  Patient problems: Laceration(s)

  MAUDE report 24566805 ↗
• MalfunctionFeb 17, 2026Detachment 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 24366885 ↗
• MalfunctionFeb 6, 2026Detachment 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 24275509 ↗