Z-1016-2015 Class II Terminated
FDA device recall Z-1016-2015 was initiated by Mobius Imaging, LLC on December 8, 2014 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated July 6, 2015). Affected quantity: 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch.
Recall Details
- Product Type
- Devices
- Report Date
- February 4, 2015
- Initiation Date
- December 8, 2014
- Termination Date
- July 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch
Product Description
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Reason for Recall
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.
Distribution Pattern
USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
Code Information
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