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Mobius Imaging, LLC recalls Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Recalled February 4, 2015 · FDA recall Z-1016-2015 · Mobius Imaging
Hazard
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. · FDA Class II
Units
21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch
Sold at
USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
Description
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.
Product
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Manufacturer(s)
Mobius Imaging, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →