Recall Z-0509-2018 ยท JAK System, X-Ray, Tomography, Computed
Brainlab AG
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
| Date | Jul 28, 2017 |
| Status | Terminated |
| Reason | Risk of unintended motion while the AIRO system is in transport mode. |
| Root cause | Component design/selection |
| Action | AIRO customers were issued Field Safety Notices dated June 29, 2017. The letter identified the affected product, problem and actions to be taken. A warning label was provided to be placed on the system. For questions contact your local Brainlab Customer Support Representative. |
| Quantity | 102 |
| Distribution | Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160126 | AIRO Computed Tomography (CT) X-ray System Mobius Imaging, Apr 19, 2016 |