BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1016-2015 · Initiated December 8, 2014

    Recall

    Recall Number
    Z-1016-2015
    Event Number
    69993
    Firm
    Mobius Imaging, LLC
    FEI Number
    3010151377
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 8, 2014
    Posted
    January 27, 2015
    Terminated
    July 6, 2015
    Address
    323 W Main St, Ayer, MA, 01432-1239

    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.

    Action

    Mobius sent an Urgent Field Safety Notice dated December 8, 2014, to all affected customers. The letter explains the recall and provides advise on action to be taken by the user. The letter also informs consignees that Mobius Imaging is working on a software fix for the software bug/communication error. The final fix is anticipated in early 2015. Advise on action to be taken by the user: The user should be prepared for the potential necessity to perform a manual navigation registration in order to use navigation. In general, do not use navigation data transmitted by the AIRO Mobile CT Scanner of any scan the Brainlab AIR App displayed the "Received Wrong Dataset" error for. To use such scans with the Curve, a manual navigation registration is required. To avoid the possibility of incorrect data from being transferred to the Curve, Mobius Imaging is recommending that customers only select "NO" when they come to the "Continue with same patient" screen after each scan. They can select the same patient under the "Existing Patients" tab and restart the workflow. Additionally, always adequately verify the accuracy of the navigation registration data as required by the Brainlab Curve" Navigation system software and the AERO Operator's Manual. If you require further clarification, please feel free to contact your local Brain lab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1800 597 5911 (for US customers) or by E-mail: [email protected] (for US customers: [email protected]) Fax Brainlab AG: + 49 89 99 15 68 33 Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany. For questions regarding this recall call 978-615-5025.

    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