Recall Z-1016-2015— Mobius Imaging, LLC

Name: FDA recall Z-1016-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-08

Class II · Terminated

Class II FDA medical device recall by Mobius Imaging, LLC, initiated 2014-12-08, terminated 2015-07-06. It names one FDA 510(k) clearance: K131431. Product: Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.. Reason: 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..

Recalling firm: Mobius Imaging, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-12-08
Terminated: 2015-07-06
Firm location: Ayer, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K131431 — AIRO CT SYSTEMMobius Imaging, LLC·cleared 2013-09-26

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

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.

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