Device recall
Z-1704-2019: AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero…
FDA device recall · Class II · Angiodynamics Inc. (Navilyst Medical Inc.)
Key facts
| Recall number (Z-number) | Z-1704-2019 |
|---|---|
| Recall event | 82743 |
| Product | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are… |
| Product code | NEY |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2020 |
| 510(k) numbers | K162449 |
| FEI number | 3017892510 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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