Sep

2018

Recall – Cl II AIRO Mobile CT System

Company:Mobius Imaging, LLC..
Date of Enforcement Report 9/26/2018
Class lI:

PRODUCT

AIRO Mobile CT System Model # Mobi CT-32

Recall Number: Z-2991-2018

REASON
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..

RECALLING FIRM/MANUFACTURER
Mobius Imaging, LLC Shirley, MA on 8/1/2018 FDA Mandated: Recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
147

DISTRIBUTION
Nationally and Internationally.

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Recall – Cl II AIRO Mobile CT System

Amy Sellers

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