Device recall
Z-1607-2016: Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B…
FDA device recall · Class II · Toshiba American Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-1607-2016 |
|---|---|
| Recall event | 74005 |
| Product | Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and… |
| Product code | KPS |
| Recalling firm | Toshiba American Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 22, 2017 |
| 510(k) numbers | K140651 |
| FEI number | 2020563 |
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