Ingenia Evolution Upgrade 1.5T (REF 782166)Recalls & reported problems
Philips Medical Systems Nederland B.V. · Upgrade to the next generation portfolio for our customers having an Ingenia 1.5T (S) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- 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 · 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-1954-2026 · Root cause: Under Investigation by firm · FDA record ↗
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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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