Recall – Scanning Software Error

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

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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.