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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

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 3 reportsAug 2024: 2 reportsSep 2024: 1 reportsOct 2024: 5 reportsNov 2024: 10 reportsDec 2024: 9 reportsJan 2025: 70 reportsFeb 2025: 47 reportsMar 2025: 30 reportsApr 2025: 5 reportsMay 2025: 20 reportsJun 2025: 14 reportsJul 2025: 19 reportsAug 2025: 19 reportsSep 2025: 13 reportsOct 2025: 21 reportsNov 2025: 11 reportsDec 2025: 17 reportsJan 2026: 13 reportsFeb 2026: 11 reportsMar 2026: 12 reportsApr 2026: 9 reportsMay 2026: 15 reportsJun 2026: 5 reportsJul 2026: 7 reportsAug 2026: 4 reportsSep 2026: 13 reportsOct 2026: 0 reports20242025202670
Last 36 months. The most recent month may be incomplete.

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.

  1. 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 ↗

  2. 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 ↗

  3. 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 ↗

  4. 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 ↗

  5. 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 ↗

  6. 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 ↗

  7. 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 ↗

  8. 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 ↗

  9. 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 ↗

  10. 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 ↗

  11. 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 ↗

  12. 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 ↗

  13. 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 ↗

  14. 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 ↗

  15. 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 ↗

  16. 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 ↗

  17. 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 ↗

  18. 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 ↗

  19. 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 ↗

  20. 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 ↗

  21. 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 ↗

  22. 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 ↗

  23. 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 ↗

  24. 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 ↗

  25. 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 ↗

  26. 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 ↗

  27. 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 ↗

  28. 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 ↗

  29. 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 ↗

  30. 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.

Recent Ingenia adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Philips Medical Systems Nederland B.V. products

All Philips Medical Systems Nederland B.V. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page