Device recall
Z-0549-2021: Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product…
FDA device recall · Class II · Canon Medical System, USA, INC.
Key facts
| Recall number (Z-number) | Z-0549-2021 |
|---|---|
| Recall event | 86864 |
| Product | Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. |
| Product code | JAK |
| Recalling firm | Canon Medical System, USA, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 16, 2022 |
| 510(k) numbers | K192832 |
| 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