Z-0715-2018Class II

AIRO Mobile CT System, Model Number: MobiCT-32

Name: Z-0715-2018 AIRO Mobile CT System, Model Number: MobiCT-32
Creator: Mobius Imaging, LLC
Published: 2017-09-26
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2017-09-26 / Terminated

FDA source

Mobius Imaging, LLC began a recall of AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can... on 2017-09-26. FDA classified it as Class II and gives the reason as "If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0715-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-26
Posted: 2018-02-24
Terminated: 2018-08-16
Recalling firm: Brainlab, Inc.
Product: AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan.
FDA root cause: Under Investigation by firm
Action: Mobius sent an Urgent Field Safety Notice letter dated September 26, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Mobius Imaging is advising all customers to discontinue using the AIRO until update is completed on their system. Please provide a copy of this Field Safety Notification to all AIRO operators that use the AIRO system, and quarantine the system per hospital policies and procedures.
Quantity in commerce: 105
Distribution: Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, NC, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan
Product codes and lots: Requested.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0715-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0715-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code JAK

K160126Class IIAIRO Computed Tomography (CT) X-ray SystemMobius Imaging / cleared 2016-04-19

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)