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FDAApril 20, 2016device

GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.

What to do

FDA enforcement status: Terminated

Brands named

ge medical systems

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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