FDA-Device2015-02-04Class II
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Mobius Imaging, LLC
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.
Sold states
USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
Affected count
21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch
Manufactured in
323 W Main St, N/A, Ayer, MA, United States
Products
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1016-2015Don't want to check this manually?
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