Device recall
Z-0622-2017: Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an…
FDA device recall · Class II · Toshiba American Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-0622-2017 |
|---|---|
| Recall event | 75661 |
| Product | Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis. |
| Product code | JAK |
| Recalling firm | Toshiba American Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2017 |
| 510(k) numbers | K141741 |
| 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