BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1016-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1016-2015
    Event ID
    69993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mobius Imaging, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    December 8, 2014
    Classification Date
    January 27, 2015
    Termination Date
    July 6, 2015
    Address
    323 W Main St, N/A, Ayer, MA, 01432-1239, United States

    Description

    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.

    Code Info

    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

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

    Quantity

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