Mobius Imaging, LLC recalls AIRO Mobile CT System Model # MobiCT-32
- Recall date
- August 1, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2991-2018
- FDA classification
- Class II
- Brand / firm
- Mobius Imaging, LLC
- Sold / distributed
- US and foreign distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AIRO Mobile CT System Model # MobiCT-32
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