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FDADecember 8, 2014device

Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.

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

The hazard

There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.

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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Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system. — Recall Details · AllClear