Device recall
Z-2253-2021: Simpleware ScanIP software. For transfer of imaging information from a medical…
FDA device recall · Class II · Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Key facts
| Recall number (Z-number) | Z-2253-2021 |
|---|---|
| Recall event | 88207 |
| Product | Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. |
| Product code | LLZ |
| Recalling firm | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2022 |
| 510(k) numbers | K142779 |
| FEI number | 3011676026 |
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