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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard involves a display error that does not prevent the device from functioning as commanded, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
GE Healthcare, LLC is recalling the Definium 5000/5220493-2 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 users quickly switch protocols from AEC to Fixed under the same view, if the selection process takes less than 0.5 seconds, the UI may display different exposure techniques than those selected and may not display the AEC setting. Although the exposure can still be made as commanded, the system may not properly indicate the settings used.
Healthcare facilities using these systems should contact GE Healthcare for further instructions on resolving the display issue.
The recalled product
- Product
- GE Healthcare Definium 5000/5220493-2 X-Ray System
- Manufacturer
- GE Healthcare, LLC
- 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 5000/5220493-2
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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