Device recall
Z-1142-2019: Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems…
FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Recall number (Z-number) | Z-1142-2019 |
|---|---|
| Recall event | 80640 |
| Product | Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and… |
| Product code | JAK |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2020 |
| 510(k) numbers | K012009 |
| FEI number | 1525965 |
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