Ingenia SmartPath to dStream for XR and 3.0T (REF 782113)Recalls & reported problems
Philips Medical Systems Nederland B.V. · SmartPath to dStream integrates dStream architecture on the current 3.0T magnet, providing flexible and intelligent tools for fast exams and more consistent scanning, as well as excellent clinical performance for a variety of applications - all while increasing patient comfort. · Class 2
All models of Ingenia (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
9 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Philips Ingenia MRI scanner upgrade adds Philips' dStream software and coil architecture to a 3.0T magnet for faster, more consistent scanning. Of 38 adverse event reports, most describe the body coil's rubber seal coming loose, peeling, wearing out, or tearing, which can leave sharp magnet cover edges exposed to the patient during scanning. There are 9 open recalls, covering the seal, image reconstruction and export software errors, loose screws, and components that could produce smoke or fire.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 9
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00884838098909), received between Dec 13, 2024 and Sep 17, 2026 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 reports).
9 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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 ↗
- 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 ↗
- 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 ↗
- 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 ↗
- 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 ↗
- 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 ↗
- Mar 12, 2024Class IIOpen, Classified
Patient support table floor plate may be incorrectly installed.
Z-1590-2024 · Root cause: Process design · Recall details · FDA record ↗
- 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 ↗
Most reported problems
Device problems
- Detachment of Device or Device Component39
Patient problems
- No Clinical Signs, Symptoms or Conditions39
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Detachment of Device or Device Component
Philips received a report that the upper Quadrature Body Coil (QBC) seal has worn. 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 it is likely that this could lead to serious injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797883 ↗MalfunctionMay 21, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE 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 25239280 ↗MalfunctionApr 23, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL RUBBER RING INSIDE THE TUBE HAD BEEN TORN OUT. 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, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24964450 ↗MalfunctionMar 16, 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 24606960 ↗MalfunctionMar 10, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS 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 PEELING OFF IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24556333 ↗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 24366866 ↗MalfunctionFeb 6, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL (UPPER AND LOWER) 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 24275754 ↗MalfunctionJan 21, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS WORN 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 WORN OUT IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24128908 ↗MalfunctionJan 12, 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 24032667 ↗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 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 23836325 ↗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 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 23836321 ↗MalfunctionOct 31, 2025Detachment of Device or Device Component; Detachment 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 23433716 ↗MalfunctionOct 18, 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 23331815 ↗MalfunctionSep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL (UPPER LINER ASSEMBLY) WAS BROKEN (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 23023410 ↗MalfunctionSep 3, 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 22950113 ↗MalfunctionSep 2, 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 (WORN). 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 22932394 ↗MalfunctionAug 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 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 22839800 ↗MalfunctionAug 15, 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 22813715 ↗MalfunctionJul 9, 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 AND 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 LOOSE AND DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22456591 ↗MalfunctionJun 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 LOOSE (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 LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320944 ↗MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE MAGNET RUBBERS (QBC SEAL) WERE 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 22225792 ↗MalfunctionApr 28, 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 21916695 ↗MalfunctionApr 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 SLIPPED OUT (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 21907201 ↗MalfunctionMar 4, 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 21512519 ↗MalfunctionMar 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) COIL COVER AND SEAL WERE 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 21512302 ↗
Other System, Nuclear Magnetic Resonance Imaging devices
- Ingenia Ingenia Elition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging14 recalls12 reports
- Ingenia Elition SPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging13 recalls2 reports
- NA Discovery MR750w 3.0TGE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging13 recalls0 reports
- Ingenia Ingenia Ambition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging12 recalls12 reports
- Ingenia Ingenia 3.0T CXPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls59 reports
- Ingenia Smartpath to dStream for 3.0TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls44 reports
- Ingenia Ingenia Elition XPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls5 reports
- MR 7000 Series MR 7700Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging11 recalls4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page