Device recall
Z-0509-2018: AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-0509-2018 |
|---|---|
| Recall event | 79009 |
| Product | 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). |
| Product code | JAK |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2018 |
| 510(k) numbers | K160126 |
| FEI number | 3010151377 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database