Mobius Imaging, LLC: Medical Device Recall in 2018 - (Recall #: Z-2991-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

AIRO Mobile CT System Model # MobiCT-32

Product Classification:

Class II

Date Initiated: August 1, 2018

Date Posted: September 26, 2018

Recall Number: Z-2991-2018

Event ID: 80867

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.

Status: Terminated

Product Quantity: 147

Code Information:

Model # MobiCT-32

Distribution Pattern:

US and foreign distribution.

Voluntary or Mandated:

FDA Mandated