FDAAugust 1, 2018device

AIRO Mobile CT System Model # MobiCT-32

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

The hazard

The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.

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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