Recall Z-2991-2018— Mobius Imaging, LLC

Name: FDA recall Z-2991-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-01

Class II · Terminated

Class II FDA medical device recall by Mobius Imaging, LLC, initiated 2018-08-01, terminated 2019-12-13. It names one FDA 510(k) clearance: K180393. Product: AIRO Mobile CT System Model # MobiCT-32. 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: Mobius Imaging, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-08-01
Terminated: 2019-12-13
Firm location: Shirley, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K180393 — AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC·cleared 2018-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.