Z-1016-2015 Class II Terminated
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