GE Healthcare Definium 5000 X-Ray System UI Display Recall
GE Healthcare is recalling Definium 5000 X-Ray Systems because the user interface may display incorrect exposure settings during rapid protocol switching.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a display error where the exposure is still made as commanded, and no injuries or illnesses are reported, fitting the criteria for a moderate severity issue.
Plain-English summary
GE Healthcare, LLC is recalling the Definium 5000 / 5220493 X-Ray System. The recall involves 312 units installed in the United States with nationwide distribution.
The recall is due to a user interface (UI) defect. When quickly switching protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the UI may display different exposure techniques than those selected and may not display the AEC setting. While the exposure can still be made as commanded, it may not be properly indicated on the screen.
Healthcare facilities using these systems should contact GE Healthcare for further instructions on resolving the issue.
The recalled product
- Product
- GE Healthcare Definium 5000 / 5220493 X-Ray System
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 312
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Definium Model 5000/5220493
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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