DefiniumRecalls & reported problems across all models
GE Hualun Medical Systems Co., Ltd · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Definium model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of Definium by GE Hualun Medical Systems Co., Ltd in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Definium recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 28, 2025Open, Classified
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Z-1046-2025 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗
- Jan 28, 2025Open, Classified
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
Z-1045-2025 · Root cause: Radiation Control for Health and Safety Act · names 2 of these models · Recall details · FDA record ↗
Definium models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Definium Tempo ProSolid state x-ray imager (flat panel/digital imager)1 recall0 reports
- Definium TempoSystem, x-ray, stationary1 recall0 reports
- Definium Pace SelectSolid state x-ray imager (flat panel/digital imager)1 recall0 reports
Other GE Hualun Medical Systems Co., Ltd products
All GE Hualun Medical Systems Co., Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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