Model note · X-ray
GE HealthCare Definium 8000 digital radiographic system
The Definium 8000 is a fixed room digital radiography system launched by GE at RSNA 2005, successor to the Revolution XR/d. It pairs a ceiling mounted, motorised autopositioning tube support with amorphous silicon flat panel detectors in a wall stand and, in the full room version, under a floating tabletop. Options include Auto Image Paste for long spine and leg views and VolumeRAD digital tomosynthesis, which makes it a general purpose room for busy imaging departments.
The model
Maker, model and type.
- Maker
- GE HealthCare (GE Medical Systems), Waukesha, Wisconsin
- Model
- Definium 8000 digital radiographic system
- Device type
- X-ray
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Detector technology | Amorphous silicon flat panel, shared with the Definium AMX 700 portable | Source |
| Tube suspension | Overhead tube on ceiling rails with touchscreen, motorised five axis autopositioning and a screen rotating 90 degrees | Source |
| Configurations | Wall stand only (one detector) or full room with fixed table and wall stand (two detectors); all versions need ceiling rails | Source |
| Auto Image Paste | Joins up to five automatically positioned exposures into one image of spine or legs | Source |
| VolumeRAD | Low dose projection sweep reconstructed into multiple tomographic slices (chest, abdomen, extremities, spine) | Source |
| Model numbers seen in FDA records | 5131070 and 5135678 | Source |
| Regulatory basis | Cleared as the Revolution XR/d family, e.g. K051967 (with tomosynthesis), 21 CFR 892.1680 stationary x-ray system, Class II, product codes KPR, MQB, IZF | Source |
| Pre-installation manual | GE document 5137435-100 listed on GE site planning | Source |
Recalls
Known FDA recalls.
- Z-0584-20122011-11-22
Patient barrier rotating arms on Definium 8000 and Discovery XR650 image pasting systems may fail to hold position.
FDA record - Z-0528-20102009-08-13
Tabletops could move unexpectedly in both directions when brakes failed to engage after pedal release.
FDA record - Z-1822-20082008-03-07
VolumeRAD processing software offset wall stand slices by 17 mm.
FDA record - Z-1882-20082008-03-07
Generator software could report higher mAs than actually delivered.
FDA record - Z-1883-20082008-01-02
Manual switch for disabling positive beam limitation on the tube support was not labelled as required.
FDA record - Z-1476-20082007-08-13
Required certification labels missing from the x-ray control.
FDA record - Z-1789-20122006-05-31
Operator's finger pinched between the fixed roller and gliding tabletop of the table.
FDA record
Safety
Safety warnings from the record.
- A tabletop that floats without the pedal pressed can move a patient unexpectedly during transfer and lead to a fall. Source
- Patient barrier arms used to steady patients during image pasting may swing freely if friction is lost, affecting patient and user safety. Source
- VolumeRAD wall stand slices were offset by 17 mm before correction, so anatomy within 17 mm of the detector could be missed. Source
- A generator software error could give light images while reporting more mAs than was delivered, which affects dose records. Source
Sources
Where this note comes from.
- Diagnostic Imaging: GE introduces fixed and portable DR products (Nov 2005)
- Block Imaging: GE Definium 5000 vs Definium 8000
- FDA 510(k) K051967, Revolution XR/d with Tomosynthesis
- BfArM: GE field safety notice 05994/11, patient barrier arms
- GE HealthCare site planning
- openFDA recall search, Definium 8000
- openFDA MAUDE problem counts, Definium 8000
Not covered: GE's operator and service manuals, generator and tube ratings, detector size and error codes for the Definium 8000 are not publicly available, so specs are limited to press and FDA descriptions and errorCodes is empty. The system is a legacy product with no current GE product page; GE's public site planning drawings were checked but carry installation layouts rather than performance specifications. Recalls for the Definium 5000, AMX 700 and 656HD were excluded as different products.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.