medical Class II Updated 2025-02-12

GE Medical Systems, LLC recalls Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 0

Recalled Product

Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTINs: 00840682138598, 00195278840226, 00840682136709)
View official government recall

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