Ingenia HA FlexTrakRecalls & reported problems
Philips Medical Systems Nederland B.V. · The HA FlexTrak is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. · Class 2
All models of Ingenia (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names 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
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 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 16, 2026.
Recalls naming this device
- May 3, 2024Open, Classified
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Z-1949-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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