Device recall
Z-1289-2018: DynaCad software consist of an MR Analysis Server software and the viewer…
FDA device recall · Class II · Invivo Corporation
Key facts
| Recall number (Z-number) | Z-1289-2018 |
|---|---|
| Recall event | 79590 |
| Product | DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package… |
| Product code | LLZ |
| Recalling firm | Invivo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 4, 2020 |
| 510(k) numbers | K121517 |
| FEI number | 1000113495 |
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