Revolution Maxima USRecalls & reported problems
GE Hangwei Medical Systems Company Ltd. · Revolution Maxima CT designated medical device, WSO make · Class 2
Data updated Oct 13, 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.
5 other recalls cover devices cleared under the same FDA submission (K192686); they may or may not involve this specific model.
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
- Jun 2, 2022Open, Classified
As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.
Z-1511-2022 · Root cause: Error in labeling · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192686. One submission often covers many models, so check the product and lot details in each record.
- Z-0610-2025 · Nov 5, 2024 · Open, ClassifiedGE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
- Z-0611-2025 · Nov 5, 2024 · Open, ClassifiedGE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
- Z-0606-2025 · Nov 5, 2024 · Open, ClassifiedGE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
- Z-0612-2025 · Nov 5, 2024 · Open, ClassifiedGE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
- Z-0603-2025 · Nov 5, 2024 · Open, ClassifiedGE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
Other System, x-ray, tomography, computed devices
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
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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