Recall Z-1016-2015 ยท JAK System, X-Ray, Tomography, Computed
Mobius Imaging, LLC
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
| Date | Jan 27, 2015 (initiated Dec 8, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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 Scann |
| Quantity | 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch |
| Distribution | USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131431 | AIRO CT SYSTEM Mobius Imaging, LLC, Sep 26, 2013 |