Ingenia, Achevia, MR 5300 SmartPath to dStream for 1.5TRecalls & reported problems
Philips Medical Systems Nederland B.V. · SmartPath to dStream integrates dStream architecture on the current 1.5T 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
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 1.5T MRI scanner upgrade adds dStream technology to an existing 1.5T magnet. Of its 78 reports, 77 are malfunctions and 1 is an injury, with no deaths. Most describe a rubber seal on the scanner coming loose, which could expose patients to sharp edges. There are 9 open recalls, several about software errors, plus loose screws, a failing seal and a gradient coil fault that could cause 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
- 81
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 9
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00884838098886), received between Nov 18, 2024 and Sep 29, 2026 — classified as 1 injury, 80 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (80 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-1965-2026 · Root cause: Under Investigation by firm · 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-1788-2025 · 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-3203-2024 · 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-1589-2024 · 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-0955-2024 · Root cause: Process control · Recall details · FDA record ↗
- 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 ↗
- 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 ↗
Most reported problems
Device problems
- Detachment of Device or Device Component80
- Appropriate Device Problem Term/Code Not Available1
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- Bone Fracture(s)1
- Perforation1
- Rupture1
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927968 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Philips received a report that the QBC rubber 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 50814014 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
Philips received a report that the upper 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 50751984 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Philips received a report that the upper QBC seal of front 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 detached, it is likely that this could lead to serious injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50559145 ↗MalfunctionJul 20, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25872225 ↗MalfunctionJul 13, 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 IS COMES OFF, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25793443 ↗MalfunctionJun 26, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE RUBBER ON 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 25633421 ↗MalfunctionJun 9, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) UPPER SEAL FAILED. 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 25439277 ↗MalfunctionMay 22, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE MAGNET HOUSING QUADRATURE BODY COIL (QBC) SEAL WAS 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 COMES LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25251963 ↗MalfunctionMay 20, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE 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 25226014 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL RUBBER 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. ANLIEGEN: STÖRUNG. STÖRUNGSBESCHREIBUNG: DICHTUNG ZWISCHEN DEN COVERELEMENTEN IST DEFEKT UND MUSS ERNEUERT WERDEN. (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25214159 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE RUBBER SEAL THAT CLOSES THE GAP IN THE GANTRY INNER COVER HAD COME OFF AGAIN. 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 25168622 ↗MalfunctionMay 13, 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 25157025 ↗MalfunctionMay 8, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE BORE RUBBER 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 25122773 ↗MalfunctionMay 4, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT TART OF THE RUBBER SEAL ON THE BORE COVER INSIDE 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 DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064434 ↗MalfunctionApr 24, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE BODY COIL GASKET WAS DETACHED FROM THE FRONT CONE. 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 24975477 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) BODY RUBBER SEAL 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 COMES LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24880559 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL STRIP WAS LOOSE AND HAD COME OUT OF ITS POSITION. 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 24880556 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE FRONT CONE RUBBER ON EQUIPMENT IS ABSENT/MISSING. THIS SEAL (QBC SEAL) IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS ABSENT/MISSING, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854464 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QBC SEAL ON THE FRONT CONE 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 DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24826019 ↗MalfunctionApr 1, 2026Detachment of Device or Device Component
PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL 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 24754569 ↗MalfunctionFeb 27, 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 24468409 ↗MalfunctionFeb 27, 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 24466476 ↗MalfunctionJan 28, 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 24197703 ↗MalfunctionJan 6, 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 23971869 ↗
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