Device recall
Z-1113-2014: TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion…
FDA device recall · Class II · Toshiba American Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-1113-2014 |
|---|---|
| Recall event | 66527 |
| Product | TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This… |
| Product code | JAK |
| Recalling firm | Toshiba American Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 3, 2015 |
| 510(k) numbers | K080211 |
| 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