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FDASeptember 26, 2017device

AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

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

The hazard

If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan.

What to do

FDA enforcement status: Terminated

Brands named

mobius imagingmobius

Recall history

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

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