Ingenia Ingenia 1.5T (REF 782140)Recalls & reported problems
Philips Medical Systems Nederland B.V. · Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. · Class 2
All models of Ingenia (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
6 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
- 6
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
6 FDA recall records name this device's identifier, 6 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.
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-3308-2026 · 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-3236-2026 · Root cause: Software design · 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-2204-2025 · 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-1795-2025 · 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-3194-2024 · 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-1845-2024 · Root cause: Under Investigation by firm · Recall details · 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 14, 2026
- 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