Device recall
Z-0049-2018: Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate…
FDA device recall · Class II · Edap Technomed Inc.
Key facts
| Recall number (Z-number) | Z-0049-2018 |
|---|---|
| Recall event | 78092 |
| Product | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue |
| Product code | PLP |
| Recalling firm | Edap Technomed Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2020 |
| 510(k) numbers | K153023 |
| FEI number | 1287394 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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