Home / Recalls / Mobius Imaging, LLC / Z-2991-2018

Z-2991-2018 Class II Terminated

Recalled by Mobius Imaging, LLC — Shirley, MA

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
August 1, 2018
Termination Date
December 13, 2019
Voluntary/Mandated
FDA Mandated
Product Quantity
147

Product Description

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 Pattern

US and foreign distribution.

Code Information

Model # MobiCT-32

Other recalls by Mobius Imaging, LLC

  • Z-1040-2026 Class II — Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) (December 4, 2025)
  • Z-1041-2026 Class II — Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) (December 4, 2025)
  • Z-0957-2023 Class II — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (December 7, 2022)
  • Z-0344-2023 Class II — MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (November 18, 2022)
  • Z-0715-2018 Class II — AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is i (September 26, 2017)
  • Z-1016-2015 Class II — Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x (December 8, 2014)