FDA Device

AIRO Mobile CT System Model # MobiCT-32

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 You Should Do

Remedy

Mobius Imaging, LLC sent an URGENT MEDICAL DEVICE RECALL letter to customers advising that a voluntary recall related to the AIRO Mobile CT System was initiated. The letter included the reason for the recall and actions to be taken by the customers.

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Products

AIRO Mobile CT System Model # MobiCT-32
Brand
Mobius Imaging, LLC
UPC
Model # MobiCT-32

Units Affected

147

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