Z-2991-2018Class II

AIRO Mobile CT System Model # MobiCT-32

Name: Z-2991-2018 AIRO Mobile CT System Model # MobiCT-32
Creator: Mobius Imaging, LLC
Published: 2018-08-01
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2018-08-01 / Terminated / root cause: software

FDA source

Mobius Imaging, LLC began a recall of AIRO Mobile CT System Model # MobiCT-32 on 2018-08-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2991-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-01
Posted: 2018-09-14
Terminated: 2019-12-13
Recalling firm: Brainlab, Inc.
Product: AIRO Mobile CT System Model # MobiCT-32
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Mobius Imaging, LLC sent an URGENT MEDICAL DEVICE RECALL letter to customers advising that a voluntary recall related to the AIRO Mobile CT System was initiated. The letter included the reason for the recall and actions to be taken by the customers.
Quantity in commerce: 147
Distribution: US and foreign distribution.
Product codes and lots: Model # MobiCT-32

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2991-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2991-2018	Class II	Terminated	FDA Mandated	2018-09-26	2018-09-14

Product code JAK

K180393Class IIAIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC / cleared 2018-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)