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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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