Z-1016-2015Class II

Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system

Name: Z-1016-2015 Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system
Creator: Mobius Imaging, LLC
Published: 2014-12-08
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2014-12-08 / Terminated / root cause: software

FDA source

Mobius Imaging, LLC began a recall of Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system on 2014-12-08. FDA classified it as Class II and gives the reason as "There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect...". 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-1016-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-08
Posted: 2015-01-27
Terminated: 2015-07-06
Recalling firm: Brainlab, Inc.
Product: Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.
Root cause tag: software
FDA root cause: Software design
Action: Mobius sent an Urgent Field Safety Notice dated December 8, 2014, to all affected customers. The letter explains the recall and provides advise on action to be taken by the user. The letter also informs consignees that Mobius Imaging is working on a software fix for the software bug/communication error. The final fix is anticipated in early 2015. Advise on action to be taken by the user: The user should be prepared for the potential necessity to perform a manual navigation registration in order to use navigation. In general, do not use navigation data transmitted by the AIRO Mobile CT Scanner of any scan the Brainlab AIR App displayed the "Received Wrong Dataset" error for. To use such scans with the Curve, a manual navigation registration is required. To avoid the possibility of incorrect data from being transferred to the Curve, Mobius Imaging is recommending that customers only select "NO" when they come to the "Continue with same patient" screen after each scan. They can select the same patient under the "Existing Patients" tab and restart the workflow. Additionally, always adequately verify the accuracy of the navigation registration data as required by the Brainlab Curve" Navigation system software and the AERO Operator's Manual. If you require further clarification, please feel free to contact your local Brain lab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1800 597 5911 (for US customers) or by E-mail: [email protected] (for US customers: [email protected]) Fax Brainlab AG: + 49 89 99 15 68 33 Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany. For questions regarding this recall call 978-615-5025.
Quantity in commerce: 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch
Distribution: USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
Product codes and lots: Serial #s: 2251 (#1)*, 2324 (#2), 2328(#3), 2344 (#4), 2346 (#5), AIRO-0106, AIRO-0107*, AIRO-0108, AIRO-0110, AIRO-0111, AIRO-0112, AIRO-0113, AIRO-0114, AIRO-0115, AIRO-0116, AIRO-0117, AIRO-0118, AIRO-0119, AIRO-0120, AIRO-0122, and AIRO-0123. *Demo system

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1016-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1016-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-27

Product code JAK

K131431Class IIAiro CT SystemMobius Imaging, LLC / cleared 2013-09-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)