Mobius Imaging, LLC: Medical Device Recall in 2015 - (Recall #: Z-1016-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 8, 2014

Date Posted: February 4, 2015

Recall Number: Z-1016-2015

Event ID: 69993

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.

Status: Terminated

Product Quantity: 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch

Code Information:

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

Distribution Pattern:

USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.

Voluntary or Mandated:

Voluntary: Firm initiated