Device recall
Z-2496-2020: TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and…
FDA device recall · Class II · Tomtec Imaging Systems Gmbh
Key facts
| Recall number (Z-number) | Z-2496-2020 |
|---|---|
| Recall event | 85392 |
| Product | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI… |
| Product code | LLZ |
| Recalling firm | Tomtec Imaging Systems Gmbh |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150122 |
| FEI number | 1000185293 |
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