IngeniaRecalls & reported problems across all models
Philips Medical Systems Nederland B.V. · 54 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
124 open recalls name at least one Ingenia model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 479
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls
- 138
We found 54 models of Ingenia by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 479 adverse event reports in the FDA's MAUDE database, received between Feb 6, 2018 and Sep 28, 2026 — classified as 88 injuries, 391 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (359 reports).
138 FDA recall records name at least one of these models by its device identifier, 124 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Ingenia recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 28, 2026Open, 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-3318-2026 · Root cause: Software design · names 7 of these models · Recall details · FDA record ↗
- Aug 28, 2026Open, 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-3317-2026 · Root cause: Software design · Recall details · FDA record ↗
- Aug 28, 2026Open, 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-3316-2026 · Root cause: Software design · Recall details · FDA record ↗
- Aug 28, 2026Open, 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 · names 11 of these models · Recall details · FDA record ↗
- Aug 28, 2026Open, 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-3313-2026 · Root cause: Software design · Recall details · FDA record ↗
- Aug 28, 2026Open, 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-3312-2026 · Root cause: Software design · Recall details · FDA record ↗
- Aug 28, 2026Open, 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-3311-2026 · Root cause: Software design · names 9 of these models · Recall details · FDA record ↗
- Aug 28, 2026Open, 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-3310-2026 · Root cause: Software design · names 8 of these models · Recall details · FDA record ↗
- Aug 28, 2026Open, 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-3309-2026 · Root cause: Software design · names 4 of these models · Recall details · FDA record ↗
- Aug 28, 2026Open, 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 · names 5 of these models · Recall details · FDA record ↗
- Aug 28, 2026Open, 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-3307-2026 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Aug 21, 2026Open, 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 · names 8 of these models · Recall details · FDA record ↗
- Aug 21, 2026Open, 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-3242-2026 · Root cause: Software design · Recall details · FDA record ↗
- Aug 21, 2026Open, 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-3239-2026 · Root cause: Software design · names 7 of these models · Recall details · FDA record ↗
- Aug 21, 2026Open, 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-3238-2026 · Root cause: Software design · names 5 of these models · Recall details · FDA record ↗
- Aug 21, 2026Open, 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-3237-2026 · Root cause: Software design · names 6 of these models · Recall details · FDA record ↗
- Aug 21, 2026Open, 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 · names 6 of these models · Recall details · FDA record ↗
- Aug 21, 2026Open, 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-3235-2026 · Root cause: Software design · names 3 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1969-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1968-2026 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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 · names 2 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1966-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 14, 2026Open, 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 ↗
- Apr 14, 2026Open, 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-1963-2026 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1962-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1961-2026 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1960-2026 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1959-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1958-2026 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Apr 14, 2026Open, 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-1956-2026 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
…and 108 older recalls, listed on each model's page.
Most reported Ingenia problems
Device problems
- Detachment of Device or Device Component359
- Improper or Incorrect Procedure or Method54
- Insufficient Device Problem Information49
- Adverse Event Without Identified Device or Use Problem22
- Device Handling Problem10
- No Apparent Adverse Event6
- Misassembled During Installation5
- Appropriate Device Problem Term/Code Not Available4
Patient problems
- No Clinical Signs, Symptoms or Conditions381
- Partial thickness (Second Degree) Burn32
- Bone Fracture(s)12
- Insufficient Information10
- Full thickness (Third Degree) Burn9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Bruise/Contusion4
- Hearing Impairment4
Ingenia models
54 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ingenia Ingenia Elition XSystem, nuclear magnetic resonance imaging14 recalls12 reports
- Ingenia Smartpath to dStream for 1.5TSystem, nuclear magnetic resonance spectroscopic10 recalls131 reports
- Ingenia Ingenia Ambition XSystem, nuclear magnetic resonance imaging12 recalls12 reports
- Ingenia Ingenia 3.0T CXSystem, nuclear magnetic resonance imaging11 recalls59 reports
- Ingenia Smartpath to dStream for 3.0TSystem, nuclear magnetic resonance imaging11 recalls44 reports
- Ingenia Ingenia Elition XSystem, nuclear magnetic resonance imaging11 recalls5 reports
- Ingenia Ingenia Elition SSystem, nuclear magnetic resonance imaging11 recalls3 reports
- Ingenia Ingenia Ambition SSystem, nuclear magnetic resonance imaging11 recalls2 reports
- Ingenia Ingenia Ambition XSystem, nuclear magnetic resonance imaging11 recalls2 reports
- Ingenia Ingenia 1.5TSystem, nuclear magnetic resonance spectroscopic10 recalls24 reports
- Ingenia Ingenia 3.0TSystem, nuclear magnetic resonance imaging10 recalls21 reports
- Ingenia Ingenia Elition XSystem, Nuclear Magnetic Resonance Imaging10 recalls1 report
- Ingenia SmartPath to dStream for XR and 3.0TSystem, Nuclear Magnetic Resonance Imaging9 recalls39 reports
- Ingenia Ingenia 3.0TSystem, nuclear magnetic resonance spectroscopic9 recalls9 reports
- Ingenia Ingenia 1.5TSystem, nuclear magnetic resonance imaging9 recalls3 reports
- Ingenia Ingenia 3.0TSystem, nuclear magnetic resonance imaging9 recalls1 report
- Ingenia Ingenia Ambition XSystem, Nuclear Magnetic Resonance Imaging9 recalls1 report
- Ingenia SmartPath to Ingenia Elition XSystem, Nuclear Magnetic Resonance Imaging9 recalls0 reports
- Ingenia Upgrade to MR 7700System, Nuclear Magnetic Resonance Imaging9 recalls0 reports
- Ingenia Ingenia 1.5TSystem, nuclear magnetic resonance imaging8 recalls14 reports
- Ingenia Ingenia Ambition SSystem, nuclear magnetic resonance imaging8 recalls1 report
- Ingenia Ingenia 1.5TSystem, nuclear magnetic resonance imaging8 recalls1 report
- Ingenia Ingenia 3.0T CXSystem, nuclear magnetic resonance imaging7 recalls41 reports
- Ingenia SmartPath to dStream for XR and 3.0TSystem, Nuclear Magnetic Resonance Imaging7 recalls1 report
- Ingenia Evolution Upgrade 1.5TSystem, Nuclear Magnetic Resonance Imaging7 recalls0 reports
- Ingenia Ingenia Elition XSystem, nuclear magnetic resonance imaging7 recalls0 reports
- Ingenia Ingenia Elition SSystem, Nuclear Magnetic Resonance Imaging7 recalls0 reports
- Ingenia Ingenia 1.5TSystem, nuclear magnetic resonance imaging6 recalls0 reports
- Ingenia Evolution Upgrade 3.0TSystem, Nuclear Magnetic Resonance Imaging6 recalls0 reports
- Ingenia Ingenia Ambition SSystem, Nuclear Magnetic Resonance Imaging6 recalls0 reports
- Ingenia Ingenia 1.5TSystem, Nuclear Magnetic Resonance Imaging6 recalls0 reports
- Ingenia Evolution Upgrade 3.0TSystem, Nuclear Magnetic Resonance Imaging6 recalls0 reports
- Ingenia Evolution Upgrade 1.5TSystem, Nuclear Magnetic Resonance Imaging6 recalls0 reports
- Ingenia SmartPath to dStream for 3.0TSystem, Nuclear Magnetic Resonance Imaging5 recalls27 reports
- Ingenia SmartPath to Ingenia Elition XSystem, Nuclear Magnetic Resonance Imaging5 recalls0 reports
- Ingenia SmartPath to dStream for 1.5TSystem, Nuclear Magnetic Resonance Imaging3 recalls25 reports
- Ingenia Ingenia Elition XSystem, Nuclear Magnetic Resonance Imaging2 recalls0 reports
- Ingenia Ingenia Ambition XSystem, Nuclear Magnetic Resonance Imaging2 recalls0 reports
- Ingenia Evolution Upgrade 3.0TSystem, Nuclear Magnetic Resonance Imaging2 recalls0 reports
- Ingenia SmartPath to Ingenia Elition XSystem, Nuclear Magnetic Resonance Imaging2 recalls0 reports
- Ingenia Evolution Upgrade 1.5TSystem, Nuclear Magnetic Resonance Imaging2 recalls0 reports
- Ingenia HA FlexTrakSystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia HA FlexTrak IISystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia Upgrade dStreamSystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia Ingenia Elition SSystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia Ingenia Ambition SSystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia SmartPath to dStream for 3.0TSystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia SmartPath to dStream for 1.5TSystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia BlueSeal SESystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia BlueSeal XESystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia MR 7700System, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia MR 5300System, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia Ingenia Elition XSystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
- Ingenia Evolution Upgrade 1.5TSystem, Nuclear Magnetic Resonance Imaging1 recall0 reports
Recent Ingenia adverse event reports
The 15 most recent reports across all models, 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 22, 2026Insufficient Device Problem Information
Philips received a report that during an MR examination, artifacts appeared and the scan was interrupted. These artifacts turned out to be caused by a broken terminal connection on the Gradient coil. There was no sign of smoke or burning smell and no patient or users were harmed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853284 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Philips received a report that the rubber on the Quadrature Body Coil (QBC) 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 damaged/comes off, it is likely that this could lead to serious injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50814013 ↗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 ↗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 ↗InjurySep 15, 2026Insufficient Device Problem Information
Philips received a report that a 69-year-old female patient sustained a second-degree thermal burn with blistering on the upper left arm during an MRI examination. During the scan, the patient experienced an intense sensation of heat and activated the nurse call button. Following completion of the examination, a burn injury measuring approximately 1 × 3 cm with blister formation was identified. The reported injury was documented with supporting photographs, a second degree burn with a blister >2.5 cm occurred. The patient was treated with a cool, damp cloth to the affected area. Given the severity of the injury, the presence of a second-degree burn with blistering, and the inability to rule out the potential for permanent impairment, the event meets the criteria for a serious injury. Therefore, this event has been determined to be reportable.
Patient problems: Blister; Partial thickness (Second Degree) Burn; Skin Burning Sensation
MAUDE report 50766660 ↗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 ↗InjurySep 2, 2026Improper or Incorrect Procedure or Method
Patient problems: Bruise/Contusion; Insufficient Information
MAUDE report 50561666 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50559151 ↗MalfunctionAug 27, 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 50468155 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291935 ↗
Other Philips Medical Systems Nederland B.V. products
- Allura Xper FD19 models · 15,187 reports · 84 recalls
- Azurion22 models · 9,199 reports · 71 recalls
- IntelliSpace Cardiovascular11 models · 439 reports · 3 recalls
- MR 7000 Series2 models · 4 reports · 11 recalls
- Dynamic Coronary Roadmap3 models · 10 reports · 9 recalls
- MR 5000 Series3 models · 11 reports · 8 recalls
- Brilliance iCT2 models · 9 reports · 8 recalls
- Zenition2 models · 101 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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