FDA recall Z-2991-2018

Mobius Imaging, LLC · Class II · device

Product

AIRO Mobile CT System Model # MobiCT-32

Reason for recall

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.

Distribution

US and foreign distribution.

Key facts

Status: Terminated
Initiation date: 2018-08-01
Report date: 2018-09-26
Termination date: 2019-12-13
Voluntary/Mandated: FDA Mandated
Location: Shirley, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2991-2018